K232382 · Tandem Diabetes Care, Inc. · QJI · Nov 3, 2023 · Clinical Chemistry
Device Facts
Record ID
K232382
Device Name
Control-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
Product Code
QJI · Clinical Chemistry
Decision Date
Nov 3, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1356
Device Class
Class 2
Attributes
Software as a Medical Device, Therapeutic, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K232382 · Nov 3, 2023
Control-IQ Technology
Tandem Diabetes Care, Inc.
T1D Exchange clinic registry
The sponsor utilized data from the T1D Exchange clinic registry as a historical benchmark to evaluate the safety (severe hypoglycemia event rate) of the Control-IQ 1.5 device in the 'Higher-IQ' clinical study.
registry; safety benchmarking; severe hypoglycemia
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Control-IQ Technology for High Insulin Users with Type 1 Diabetes (Higher-IQ); Single-arm, multi-center, prospective clinical study; Follow-up/Duration: 13 weeks
Individuals with type 1 diabetes (age >= 18) planning to use at least one basal rate > 3 units/hour; Sample Size: 34 participants; Number of Sites: 4
T1D Exchange clinic registry data (historical)
Severe hypoglycemia, diabetic ketoacidosis, UADEs, SAEs
Indications for Use
Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater. Control-IQ technology is intended for single patient use and requires a prescription.
Device Story
Software-only device for Type 1 diabetes management; installed on compatible ACE insulin pumps. Inputs: iCGM glucose readings; user-provided data (carbohydrate intake, exercise, sleep schedule); total daily insulin requirement. Operation: Closed-loop control of basal insulin delivery; automatically increases, decreases, or suspends basal rates based on iCGM readings and glucose predictions; delivers automatic correction boluses when glucose predicted to exceed threshold. Modes: Normal, Sleep, Exercise (each with specific glucose target ranges). Output: Automated insulin delivery adjustments; integrated bolus calculator populated with iCGM values. Used by patients in home/daily settings; requires physician-established insulin settings. Benefits: Improved glycemic control; reduced hypoglycemia/hyperglycemia risk via automated insulin modulation.
Clinical Evidence
Pivotal randomized controlled trial (2:1 ratio) of 102 subjects aged 2-5 years. Subjects used t:slim X2 pump with Control-IQ for 13 weeks, followed by an optional 13-week extension. Primary endpoint: CGM-measured percent time in range (70-180 mg/dL). Study demonstrated safety and effectiveness for the expanded age range.
Technological Characteristics
Software-only glycemic controller. Operates on ACE insulin pumps. Connectivity: Integrates with iCGM via wireless protocol. Algorithm: Closed-loop, rule-based/predictive logic. Configurable parameters: Weight (20-440 lbs), Total Daily Insulin (5-200 U/day), Correction Factor (10-600 mg/dL/U). No hardware materials; software-based control.
Indications for Use
Indicated for management of Type 1 diabetes mellitus in persons 2 years of age and older. Requires prescription. Intended for use with compatible iCGM and ACE pumps.
Regulatory Classification
Identification
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (
*e.g.,* more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
(ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
(iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (
*e.g.,* specification of glucose sensor performance) or accept commands from (*e.g.,* specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
(vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place (
*e.g.,* validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
(2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures to address device system hazards;
(ii) Design decisions related to how the risk control measures impact essential performance; and
(iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to connected devices;
(ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices;
(iii) Sharing of necessary state information between the controller and any connected devices (
*e.g.,* battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
(v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and
(vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
(4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include:
(i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
(ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (
*e.g.,* infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
(iv) Connectivity events (
*e.g.,* establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
(6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
(7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
(8) The labeling required under § 809.10(b) of this chapter must include:
(i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
(ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
(iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
(iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section.
(v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
(vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section.
(vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
### I Background Information:
A 510(k) Number
K232382
B Applicant
Tandem Diabetes Care, Inc.
C Proprietary and Established Names
Control-IQ Technology
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QJI | Class II | 21 CFR 862.1356 – Interoperable Automated Glycemic Controller | CH - Clinical Chemistry |
E Purpose for Submission:
Modification to a cleared device to expand the age indication (from ≥ 6 years old to ≥ 2 years old) and to provide configurable parameters for the more insulin sensitive and insulin resistant device users with expansion of programmable ranges (i.e., total daily insulin dose, body weight, correction factor), extension of the maximum bolus duration, availability of temporary basal rates with Closed-Loop active, and elimination of the prior hourly basal rate limit.
### II Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater.
Control-IQ technology is intended for single patient use and requires a prescription.
### **C Special Conditions for Use Statement(s):**
*Due to an administrative error, a special condition for use limiting use to the Dexcom G6 iCGM was erroneously included and is now removed.*
Rx - For Prescription Use Only
Only use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
When the CGM reading is automatically populated into the bolus calculator, only the current CGM reading is used to calculate the correction bolus. The trend arrow is not used in the dose calculation. Speak with your healthcare provider for recommendations on how best to utilize the arrows for your correction bolus dosing.
Control-IQ technology should not be used in anyone under the age of two years old. Control-IQ technology should also not be used in patients who require less than a total daily insulin dose of 5 units per day or who weigh less than 20 pounds, as those are the required minimum values needed in order for Control-IQ technology to operate safely.
When using the Control IQ algorithm, wear an iCGM.
The t:slim X2 pump, transmitter, and sensor must be removed before Magnetic Resonance Imaging (MRI), and Computed Tomography (CT) scan. Exposure to MRI, CT, or diathermy treatment can damage the components.
DO NOT use Control-IQ technology if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your Dexcom G6 CGM readings may be falsely elevated and result in over-delivery of insulin that could result in severe hypoglycemia.
### **III Device Description**
Control-IQ technology (Control-IQ, the device) is a software-only device intended for use by people with diabetes. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ technology is meant to be installed on a compatible ACE pump.
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Control-IQ technology works to control glucose towards a glucose target range of 112.5-160 mg/dL during normal use. Glucose targets are not customizable but can be changed by a user if sleep or exercise modes are set or announced. During sleep mode, this range is changed to 112.5-120 mg/dL, and it is changed to 140-160 mg/dL during exercise mode.
Control-IQ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when the Control-IQ technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.
Using Control-IQ technology requires that users input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.
# IV Substantial Equivalence Information:
# A Predicate Device Name(s):
Control-IQ Technology
# B Predicate 510(k) Number(s):
K200467
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232382 | K200467 |
| --- | --- | --- |
| Device Trade Name | Control-IQ Technology | Control-IQ Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is | Same |
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| | predicted to exceed a predefined threshold. | |
| --- | --- | --- |
| **General Device Characteristic Differences** | | |
| Intended User Population | 2 years and older with Type 1 diabetes mellitus. | 6 years and older with Type 1 diabetes mellitus. |
| Profile delivery | The user's profile basal rate may be set as high as 15 units/hr when Control-IQ is off and when Control-IQ is enabled same basal rate is applied. | The user's profile basal rate may be set as high as 15 units/hr when Control-IQ is off, but is clipped to 3 units/hr when Control-IQ is enabled. |
| Correction Factor | The personal profile correction factor ranges from 10 to 600 mg/dL/U. | The personal profile correction factor ranges from 10 to 200 mg/dL/U. |
| Body weight range | 20 – 440 pounds | 55 – 308 pounds |
| Total Daily Insulin Range | User setting: 5 – 200 U/day Automatic adjustment: 2.5 – 200 U/day | User setting: 10 – 100 U/day Automatic adjustment: 5 – 200 U/day |
| Extended Bolus | Up to 8-hour duration while Control-IQ is enabled or disabled and extended boluses are uninterrupted when enabling Control-IQ. | Up to 2-hour duration when Control-IQ is enabled and 8-hours with Control-IQ disabled. |
| Temporary Basal Rates | Can be enabled without turning off Control-IQ. | For using Temporary rates, Control-IQ must be turned off. |
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## **V Standards/Guidance Documents Referenced:**
Special controls established under 21 CFR 862.1356.
ISO 14971:2007: Medical Devices - Application of Risk Management to Medical Devices FDA Recognition No: 5-40
## **VI Performance Characteristics:**
### **A. Analytical Performance**
For the purposes of analytical and clinical validation testing, the Control-IQ algorithm was installed on the t:slim X2 Insulin Pump with Interoperable Technology ACE pump (K232380), which was paired with the Dexcom G6 continuous glucose monitoring system (K223931).
### **B. Other Supportive Instrument Performance Characteristics Data**
#### **1. Summary of Clinical Testing**
The sponsor conducted a 13-week randomized controlled trial (RCT) in subjects 2 to 6 years old with type 1 diabetes to evaluate the performance of the original Control-IQ algorithm (i.e., Control-IQ 1.0 and the predicate device and not the modified 1.5 version that is the subject of this clearance) to support the expansion of the age indication of this device to include Type 1 diabetes users down to 2 years old. The sponsor then conducted an Extension Phase of the pivotal study in which all subjects who participated in the RCT transitioned to Control-IQ 1.5 for 13 weeks. This version of Control-IQ 1.5 (device being cleared) does not alter the control algorithm of the device itself, rather, it includes a wider range for several configurable parameters (e.g., weight, total daily insulin, etc.) which are intended to make the system amenable to address the unique needs of very insulin sensitive and very insulin resistant users. The sponsor refers to this updated version as Control-IQ 1.5 in the clinical performance section of the device user guide. To be consistent with the user guide of the subject device, throughout this section of the document, we refer to it as Control IQ 1.5.
After the Extension Phase was completed, the sponsor offered study subjects the opportunity to continue using the Control-IQ 1.5. This phase is being referred to as Extended Use phase. This phase ran for in two phases, first for 13 weeks, following which it continued with fewer patients for another 13 weeks.
In summary, the clinical data to support the age expansion in the IFU of the device is comprised of (1) the RCT comparing previously cleared Control-IQ (K200467) with standard care, (2) the Extension phase prospectively evaluating the performance of Control-IQ 1.5 by users who were already experienced in using the cleared Control-IQ 1.0 in the RCT as well as subjects naïve to Control-IQ 1.0 who continued to use standard care (e.g. multiple daily injections and insulin pump use that do not possess the hybrid closed loop capabilities that Control-IQ offers) during the RCT, and (3) the prospective evaluation for up to 1 year, referred to as Extended Use of Control-IQ 1.5 primarily for safety of the same subjects who had used the modified Control-IQ for 13 weeks in the Expansion Phase. Further details about the study is provided below.
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| Study Feature | Description |
| --- | --- |
| Title | The Pediatric Artificial Pancreas (PEDAP) trial: A Randomized Controlled Comparison of the Control-IQ technology Versus Standard of Care in Young Children in Type 1 Diabetes |
| Study Design | Randomized, prospective, multicenter clinical trial |
| Number of Sites | 3 |
| Population | Children under 6 years of age who were diagnosed with type 1 diabetes and were using insulin for at least a year were eligible for the study. |
| Sample Size | 102 participants |
| Treatment Groups | Pediatric (2 to < 6 years): Participants were randomly assigned 2:1 to an intervention using Tandem t:slim X2 with Control-IQ Technology or the standard care (SC) control group using existing insulin therapy in conjunction with study CGM. |
| Study Duration | 13 weeks |
| Protocol Overview/Synopsis | To assess efficacy, quality of life, and safety of a closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) in a randomized controlled trial. **Key Eligibility Criteria** *Inclusion* 1. The study cohort included children 2 to <6 years old with type 1 diabetes (T1D) for at least 6 months and using insulin for at least 6 months. 2. Participants’ total daily insulin dose had to be at least 5 U/day, with body weight at least 20 lbs. *Exclusion* 1. use of any non-insulin glucose-lowering agent; hemophilia or any other bleeding disorder. 2. >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months 3. >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis 4. history of chronic renal disease or currently on hemodialysis; 5. history of adrenal insufficiency 6. hypothyroidism that was not adequately treated or any other condition, which in the opinion of the investigator or designee, would put the participant or study at risk 7. current use of a hybrid closed-loop (HCL) system. The study also had a run-in phase. Eligible participants not using a Dexcom G5 or Dexcom G6 continuous glucose monitor (CGM) meeting minimum usage requirements initiated a run-in phase of 2 to 6 weeks that was customized based on whether the participant was already a CGM user. Participants who were already using Dexcom G5 or G6 could skip the run in-phase. |
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| Study Feature | Description |
| --- | --- |
| | *Primary Endpoints* CGM-measured % in range 70–180 mg/dL *Key Safety Outcomes* • severe hypoglycemia • diabetic ketoacidosis • other serious adverse events |
# Demographics
| Pediatric Study | Standard Care (N = 34) | Control-IQ 1.0 (N = 68) |
| --- | --- | --- |
| *Age Mean (SD)* | 4.06 (1.25) | 3.84 (1.23) |
| 2 to < 4 | 16 (47%) | 31 (46%) |
| 4 to < 6 | 18 (53%) | 37 (54%) |
| **Sex – Female n (%)** | 19 (56%) | 33 (49%) |
| **Diabetes Duration (years)** | | |
| Median (IQR) | 1.04 | 1.40 |
| Range | 0.50 to 4.00 | 0.51 to 5.00 |
| **HbA1c Level at Randomization (%)** | | |
| *Mean (SD)* | 7.7 (0.9) | 7.5 (1.2) |
| <7.0 | 8 (25%) | 23 (36%) |
| 7.0 to < 8.0 % | 8 (25%) | 20 (31%) |
| 8.0 to % <9.0 % | 15 (47%) | 15 (23%) |
| ≥9.0 % | 1 (3%) | 6 (9%) |
| Range | 6.0 to 9.7 | 5.2 to 11.5 |
| **Race/Ethnicity** | | |
| White non-Hispanic | 25 (74%) | 50 (74%) |
| Black non-Hispanic | 2 (6%) | 4 (6%) |
| Hispanic or Latino | 5 (15%) | 11 (16 %) |
| Asian | 1 (3%) | 1 (1 %) |
| More than one race | 1 (3%) | 2 (3%) |
# Observed Results for PEDAP Study
| | Control-IQ 1.0 (N=67) | Standard of Care (N=34) |
| --- | --- | --- |
| **% Time<54 mg/dL** | | |
| Baseline Mean (SD) | 0.6 (0.7) | 0.5 (0.6) |
| Week 13 mean (SD) | 0.6 (0.6) | 0.5 (0.5) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 0.01 (-0.1, 0.1) | |
| **% Time 70-180 mg/dL** | | |
| Baseline Mean (SD) | 57 (18) | 55 (15) |
| Week 13 mean (SD) | 69 (11) | 56 (13) |
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| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 12.4 (9.5, 15.3) [< 0.001] | |
| --- | --- | --- |
| Mean Glucose (mg/dL) | | |
| Baseline Mean (SD) | 173 (36) | 176 (36) |
| Week 13 Mean (SD) | 155 (20) | 174 (22) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 5.4 (-7.3, -3.6) [<0.001] | |
| Change in HbA1c after 13 Weeks | | |
| Baseline | 7.5 (1.2) | 7.7 (0.9) |
| Week 13 | 7.0 (0.8) | 7.5 (0.9) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | -0.42 (-0.62, -0.22), [<0.001] | |
# Extension Phase of PEDAP Study
The extension phase assessed the change in time in range for each of the treatment groups (Control-IQ 1.5 versus Standard of Care) compared to the RCT phase of the study. The key safety outcomes were severe hypoglycemia and ketoacidosis. In this phase the standard care group switched over to use of Control-IQ 1.5. The data used in the table below was based on 63 subjects continuing Control-IQ 1.5, and 33 switching over from Standard of Care to Control-IQ 1.5. The HbA1c measurements were taken from 55 of the subjects who remained on Control IQ and 28 of the subjects who migrated from Standard of Care to Control-IQ 1.5.
| | Control-IQ 1.0 to Control-IQ 1.5 | Standard of Care to Control-IQ 1.5 |
| --- | --- | --- |
| % Time<54 mg/dL | | |
| Baseline Mean at 13 weeks (SD) | 0.6 (0.5) | 0.5 (0.6) |
| Weeks 14 - 26 (SD) | 0.5 (0.4) | 0.4 (0.3) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | -0.1 (-0.2, 0.02) [0.08] | -0.1 (-0.2, -0.02) [0.02] |
| % Time 70-180 mg/dL | | |
| Baseline Mean (SD) | 70 (11) | 56 (13) |
| Week 13 mean (SD) | 70 (11) | 68 (9) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 0.1 (-1.2, 1.4) [0.86] | 11.8 (9.6, 14.1) [< 0.001] |
| Mean Glucose (mg/dL) | | |
| Baseline Mean at 13 weeks (SD) | 154 (18) | 173 (23) |
| Weeks 14 - 26 (SD) | 155 (20) | 159 (15) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 1.2 (-1.5, 3.8) [0.40] | -15.7 (-20.1, -11.2) [<0.001] |
| Change in HbA1c after 13 Weeks | | |
| Baseline Mean at 13 weeks (SD) | 7.0 (0.7) | 7.5 (0.9) |
| Weeks 14 - 26 (SD) | 7.1 (0.8) | 7.2 (0.7) |
| Adjusted Group Difference over 13 weeks (95% CI) [p-value] | 0.09 (0.01, 0.17), [0.03] | -0.36 (-0.53, 0.19) [<0.001] |
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## Ancillary Meal Challenges
The sponsor also provided the incorporation of stress challenges during the Extension Phase to further characterize the safety of the modified Control-IQ glycemic controller by evaluating the potential risks of device use in less frequently encountered, but plausible scenarios. The challenges included 38 of the Extension Phase study subjects using predicate device and consisted of a missed meal bolus, full meal bolus + exercise, and an exercise only challenge. Glycemic control was not optimal during stress challenges as observed during non-stress periods but the trends were within ranges to be expected during these challenges. The sponsor reported no events of severe hypoglycemia or hyperglycemia/ketosis/DKA during or after (including overnight) any of the challenges.
## Extended Use Study
The sponsor also provided clinical data for the Extended Use period in which 80 of the original 96 subjects in the Extension Phase opted to continue using Control-IQ 1.5. Some subjects used Control-IQ 1.5 for 3 to < 6 months (35 subjects of 102 from the original RCT, 34%) and 6 to <9 months (49 subjects of 102 from the original RCT, 48%). Sixty (60) subjects completed 13 weeks and ten (10) subjects completed 26 weeks of the Extended use Phase although 43 subjects continued with Control-IQ 1.5 beyond 13 weeks, but completed their final study visit sometime before 26 weeks. The reported CGM-metrics and safety data from the extended phase is consistent with the observed performance of Control-IQ 1.5 in the Extension study and further supports that the updated iAGC is generally comparable and no worse than Control-IQ 1.0 as observed in the RCT Phase of the PEDAP study.
## Safety Results for PEDAP Study including Extension Phase and Extended Use
Since the extension phase involved those receiving standard care in the first 13 weeks to cross over to using the Control-IQ hence the extension phase and the subsequent extended use phases safety results have been presented in a combined fashion. Note that the first 13 weeks of the Extended Use study had 80 participants following which 52 participants completed the second 13-week period of the Extended Use Study.
| | PEDAP Study | | Extension Phase of PEDAP Study | Extended Use of PEDAP Study |
| --- | --- | --- | --- | --- |
| | Control - IQ 1.0 (N=68) | Standard of Care (N=34) | Control-IQ 1.5 (N=96) | Control-IQ 1.5 (N ≥ 52) |
| **Total Number of Adverse Events (AEs)** | 41 | 14 | 75 | 33 |
| Number of Severe Hypoglycemia Events per Participant n (%) | | | | |
| ≥1 | 2 (3 %) | 1 (3 %) | 2 (3 %)† | 0 |
| Incidence Rate per 100 Person-Years | 11.6 | 11.7 | 12.5 | 0 |
| Diabetes Ketoacidosis (DKA Events) | | | | |
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| | PEDAP Study | | Extension Phase of PEDAP Study | Extended Use of PEDAP Study |
| --- | --- | --- | --- | --- |
| | Control - IQ 1.0 (N=68) | Standard of Care (N=34) | Control-IQ 1.5 (N=96) | Control-IQ 1.5 (N ≥ 52) |
| Number of DKA Events per Participant n (%) | 1 (1%) | 0 (0 %) | 0 (0 %) | 0 |
| 0 | 27 | 23 | 0 | 0 |
| 1 | 24 | 8 | 0 | 0 |
| Incidence Rate per 100 Person-Years | 413 | 163 | 0 | 0 |
| Other Serious Adverse Device Events (SADEs) | | | | |
| Number of Events | 2 | | 2† | 1 |
| Other Adverse Events (N Events/N Participants) | | | | |
| Hyperglycemia with or without Ketosis Not Related to Study Device | 12/9 | 8/7 | 28/26 | 31/14 |
| Hyperglycemia with or without Ketosis Related to Study Device | 39/26 | - | 22/12 | 29/18 |
† Includes only those who migrated from Control IQ to Control IQ 1.5
## Higher IQ Study Using Control-IQ1.5
The sponsor conducted a small study to address the safety of modified configurable parameters that aim to improve the user experience for T1D individuals with insulin resistance. The changes from Control-IQ 1.0 to Control-IQ 1.5 include (1) allowed entry of a maximum body weight up to 440 pounds, (2) allowing a basal rate of 3 units/hour to continue from manual mode when users activate CIQ 1.5, (3) enabling use of temp rates during Control-IQ 1.5 active, (4) enabling extended bolus delivery with Control-IQ 1.5 being active. Subjects in this study were allowed to continue medications for glucose control and or weight loss. Fifteen subjects in this study used a basal rate >3 units/hour 24 hours per day during the study
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| Study Feature | Description |
| --- | --- |
| Title | Control-IQ Technology for High Insulin Users with Type 1 Diabetes (Higher-IQ) |
| Study Design | Single-arm, multi-center, prospective clinical study. Existing insulin pump users (to include automated insulin delivery (AID) users) used the study system (pump and Continuous Glucose Monitoring (CGM)) in closed-loop mode for 13 weeks |
| Number of Sites | 4 |
| Population | Study participants enrolled based on protocol-defined inclusion/exclusion criterion |
| Sample Size | A total of 37 participants were enrolled (signed the consent form), and 34 passed screening and started the treatment period with Control-IQ technology v1.5 |
| Treatment Groups | Participants were randomly assigned 2:1 to an intervention using Tandem t:slim X2 with Control-IQ Technology or the standard care (SC) control group using existing insulin therapy in conjunction with study CGM. |
| Study Duration | 13 weeks |
| Protocol Overview/Synopsis | The study was a prospective, single-arm study of 13 weeks of home use of the Control-IQ 1.5 automated insulin delivery (AID) system in individuals with type 1 diabetes who planned to use at least one basal rate > 3 units/hour, age 18 and older. Control-IQ technology 1.5 removes the 3 unit/hour basal rate clipping that was present in earlier versions of Control-IQ technology, and allows for a wider range of weight and total daily insulin (TDI) input to the system. This study was designed to show the system functioned safely when used with user profile basal rates above 3 units/hr. **Key Eligibility Criteria** *Inclusion* 1. Age ≥ 18 years 2. Diagnosed with type 1 diabetes for at least 1 year. 3. Weight ≤ 440 pounds 4. Using an insulin pump of any brand for at least 3 months, and planned to use at least one basal rate > 3 U/h with the study pump *Exclusion* 1. Use of glucocorticoids or other medications determined by investigator to interfere with the study 2. Hemophilia or any other bleeding disorder. 3. >1 severe hypoglycemic event in the last 6 months 4. >1 DKA event in the last 6 months 5. Currently pregnant or planning to become pregnant during the time period of study participation 6. History of adrenal insufficiency |
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| Study Feature | Description |
| --- | --- |
| | 7. History of abnormal thyroid stimulating hormone that was not adequately treated or any other condition, which in the opinion of the investigator or designee, would put the participant or study at risk *Primary Endpoints* - Severe hypoglycemia (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a three-month time period - Diabetic ketoacidosis (event rate) - Number of unanticipated adverse device effects (UADEs) - Number of other serious adverse events (SAEs)*Secondary Safety Endpoints* - All adverse events - Overall % time < 54 mg/dL - Overall % time < 70 mg/dL |
### Demographics
| Higher IQ Study | Standard Analysis Set (N = 34) |
| --- | --- |
| *Age Mean (SD)* | 39.9 (11.9) |
| Sex – Female n (%) | 14 (41 %) |
| **Diabetes Duration (years)** | |
| Mean (SD) | 21.8 (11.2) |
| Range | 2.7 – 42.7 |
| **Body Mass Index (BMI)** | |
| Mean (SD) | 37.6 (5.2) |
| **HbA1c Level at Randomization (%)** | |
| *Mean (SD)* | 7.7 (1.08) |
| Range | 6.0 to 10.0 |
| **Race and or Ethnicity*** | |
| White | 34 (100%) |
| Black or African American | 2 (6%) |
| Hispanic or Latino | 3 (8.8%) |
\* Some subjects chose more than one race that they identified with.
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# Observed Results for Higher-IQ Study Using Control-IQ 1.5
| | Time (%) in BG < 54 mg/dL | Time (%) in BG < 70 mg/dL | Time (%) in BG 70 – 180 mg/dL | Time (%) in BG > 180 mg/dL | Time (%) in BG ≥ 250 mg/dL |
| --- | --- | --- | --- | --- | --- |
| **During non-challenge periods** | | | | | |
| Overall Mean ± SD | 0.20 ± 0.22 | 1.04 ± 0.98 | 64.75 ± 10.75 | 34.21 ± 11.05 | 10.45 ± 6.78 |
| 95 % CI for Mean | [0.13, 0.28] | [0.70, 1.38] | [61.00, 68.50] | [30.36, 38.07] | [8.08, 12.81] |
| **Nighttime during non-challenge period** | | | | | |
| Mean ± SD | 0.35 ± 0.42 | 1.44 ± 1.48 | 68.47 ± 14.81 | 30.09 ± 15.01 | 9.58 ± 10.39 |
| 95 % CI for Mean | [0.21, 0.50] | [0.92, 1.95] | [63.30, 73.64] | [24.85, 35.33] | [5.95, 13.20] |
| **During Skipped Bolus** | | | | | |
| Overall Mean ± SD | 0.00 ± 0.00 | 1.59 ± 4.17 | 46.99 ± 33.35 | 51.42 ± 34.35 | 27.17 ± 28.30 |
| 95 % CI for Mean | [0.00, 0.00] | [0.14, 3.05] | [35.35, 58.63] | [39.43, 63.40] | [2.53, 12.37] |
| **Nighttime following challenge period** | | | | | |
| Mean ± SD | 0.12 ± 0.71 | 0.69 ± 2.74 | 79.33 ± 26.02 | 19.98 ± 25.64 | 4.44 ± 11.56 |
| 95 % CI for Mean | [-0.13, 0.37] | [-0.26, 1.65] | [70.25, 88.41] | [11.03, 28.92] | [0.41, 8.48] |
| **During Meal challenge – half bolus** | | | | | |
| Mean ± SD | 0.31 ± 1.81 | 0.61 ± 3.17 | 68.39 ± 29.58 | 31.07 ± 30.07 | 4.49 ± 12.11 |
| 95 % CI for Mean | [-0.32, 0.94] | [-0.50, 1.72] | [58.07, 78.71] | [20.50, 41.49] | [0.26, 8.72] |
| **Nighttime following challenge period** | | | | | |
| Mean ± SD | 0.54 ± 2.34 | 1.58 ± 5.46 | 76.66 ± 27.33 | 21.77 ± 26.21 | 4.04 ± 14.90 |
| 95 % CI for Mean | [-0.28, 1.36] | [-0.33, 3.48] | [67.12, 86.19] | [12.62, 30.91] | [-1.16, 9.24] |
| **During Meal challenge – full bolus** | | | | | |
| Mean ± SD | 0.23 ± 1.35 | 0.70 ± 3.62 | 63.97 ± 32.38 | 35.33 ± 32.96 | 8.58 ± 17.06 |
| 95 % CI for Mean | [-0.24, 0.70] | [-0.57, 1.96] | [52.67, 75.17] | [23.83, 46.83] | [2.63, 14.54] |
| **Nighttime following challenge period** | | | | | |
| Mean ± SD | 0.12 ± 0.71 | 0.86 ± 3.28 | 67.97 ± 32.13 | 31.17 ± 32.21 | 6.45 ± 15.82 |
| 95 % CI for Mean | [-0.13, 0.37] | [-0.29, 2.00] | [56.76, 79.18] | [19.94, 42.41] | [0.93, 11.97] |
| **During Exercise challenges** | | | | | |
| Mean ± SD | 0.27 ± 0.90 | 1.81 ± 3.30 | 72.15 ± 15.87 | 26.05 ± 16.42 | 3.30 ± 5.45 |
| 95 % CI for Mean | [-0.04, 0.59] | [0.66, 2.96] | [66.61, 77.69] | [20.32, 31.78] | [1.39, 5.20] |
| **Nighttime following challenge period** | | | | | |
| Mean ± SD | 0.05 ± 0.32 | 0.71 ± 2.65 | 70.41 ± 20.56 | 28.88 ± 20.15 | 8.16 ± 13.98 |
| 95 % CI for Mean | [-0.06, 0.17] | [-0.21, 1.64] | [63.24, 77.58] | [21.84, 35.91] | [3.28, 13.03] |
| **Change in HbA1c at 13 week follow up** | | | | | |
| HbA1c (%) at Baseline | 7.69 ± 1.08 | | | | |
| HbA1c 95% CI for mean at Baseline | [7.32, 8.07] | | | | |
| HbA1c (%) at 13 weeks | 6.87 ± 0.57 | | | | |
| HbA1c 95% CI for mean at 13 weeks | [6.67, 7.07] | | | | |
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# Safety Results for Higher IQ study
There were no severe hypoglycemia and diabetic ketoacidosis events, and one serious adverse event of Atrial Fibrillation during the non-challenge period. This serious adverse event was unrelated to both the study procedures and the investigative device. There was a total of 37 non-serious adverse events, but majority were unrelated to the study procedure and the device.
# Additional Study
The lead-in period of another study that included 179 subjects who used Control IQ 1.5 with Humalog was used in the substantial equivalence determination. This study required every subject to complete a no-bolus meal challenge and an extended 2-hour exercise challenge was also included to provide safety data in those stress scenarios for the subject device. The sponsor reported the results for pediatrics (6 to <14-year-old) and adults (≥14 years old). Since all subjects in this study were already Control IQ users, the HbA1c was well controlled with only 57 of 179 subjects (32%) screening into the study with an HbA1c of ≥7.5%. The sponsor reported time in range 70-180 mg/dL in the ≥ 14-year-old cohort (N=70) of 69% +/- 13% and 62% +/- 15% in the 6 to <14-year-old subject cohort which is similar to the values used for > 6-year-old in the predicate device. The sponsor reported % time <70 mg/dL and <54 mg/dL as low (<1%) which is also consistent with prior evaluations of predicate device. Additional safety data in this 6- to 81-year-old cohort from the no-bolus challenge and extended exercise challenge did not yield any severe hypoglycemia or DKA events including in the overnight period after the challenge was completed.
# Postmarket Surveillance Study:
There is uncertainty remaining regarding the risk/benefit profile of the device when used in the broader intended use population. While the premarket clinical study provided to support this premarket notification showed some benefits, the study included device users and their caregivers with relatively high levels of education relative to the general use population, and it was not adequately powered to assess differences in the rates of safety events (e.g., diabetic ketoacidosis and severe hypoglycemia). Furthermore, due to the nature of the study design, the apparent unfavorable difference in the rates of hyperglycemia/ketosis events (not rising to the level of severity of diabetic ketoacidosis) between the treatment and control arms may be due to reporting differences between users rather than a true difference from the device itself.
Accordingly, the manufacturer will be performing a post-market surveillance study with subjects ages 2-5 years old.
# 2. Human Factors
The summative human factors study conducted under DEN190034 included assessment of the 2–6-year pediatric age group and their care providers, and the results were found to be acceptable.
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# 3. Software
The software changes made to this device were reviewed and found to be acceptable.
# **VII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
# **VIII Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
