Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.

Detailed Description
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This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

Official Title
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Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: t:slim X2 insulin pump with Control-IQ technology 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 2 to ≤ 81 years Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility Total Daily Insulin Dose (TDD) at least 2 units/day Weight ≥ 20 lbs HbA1c ≤ 10.5% For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight. Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol. Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices. Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) Willing and able to perform study meal challenges. Exclusion Criteria: More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months Inpatient psychiatric treatment in the past 6 months For Female: Currently pregnant or planning to become pregnant during the time period of study participation A negative pregnancy test will be required for all females of child-bearing potential Counseling on appropriate birth control options will be provided to all females of child-bearing potential Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). Hemophilia or any other bleeding disorder Hemoglobinopathy History of heart, liver, lung or kidney disease determined by investigator to interfere with the study History of allergic reaction to Humalog or Novolog Use of any medications determined by investigator to interfere with study Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea History of adrenal insufficiency History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated History of gastroparesis A condition, which in the opinion of the investigator or designee, would put the participant or study at risk Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control-IQ 2.0 Alternate Target<br>Participants will use t:slim X2 pump with Control-IQ technology 2.0 at an alternate target for two weeks. | Device: t:slim X2 insulin pump with Control-IQ technology 2.0<br>* t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.<br>|
| Experimental: Control-IQ 2.0 Standard Target<br>Participants will use t:slim X2 pump with Control-IQ technology 2.0 at a standard target for two weeks. | Device: t:slim X2 insulin pump with Control-IQ technology 2.0<br>* t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe hypoglycemic events | Number of severe hypoglycemic events (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 3-month time period | 6 weeks | 
| Number of diabetic ketoacidosis (DKA) events | Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period | 6 weeks | 
| Number of unanticipated adverse device effects (UADEs) | Number of unanticipated adverse device effects during the study. | 6 weeks | 
| Number of other serious device-related adverse events | Number of serious device-related adverse events during the study. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All device-related adverse events | Number of device-related adverse events | 6 weeks | 
| Percent of time <54 mg/dL | CGM percent time <54 mg/dL during each study period. | 6 weeks | 
| Percent of time <70 mg/dL | CGM percent time <70 mg/dL during each study period. | 6 weeks | 
| Percent time 70-180 mg/dL | CGM percent time 70-180 mg/dL during each study period. | 6 weeks | 
| Percent time > 180 mg/dL | CGM percent time >180 mg/dL during each study period. | 6 weeks | 
| Percent time > 250 mg/dL | CGM percent time >250 mg/dL during each study period. | 6 weeks | 
| Percent time 70-140 mg/dL | CGM percent time 70-140 mg/dL during each study period. | 6 weeks | 
| Mean glucose | Mean CGM glucose mg/dL during each study period. | 6 weeks | 
| Coefficient of variation | Coefficient of variation mg/dL during each study period. | 6 weeks | 
| Standard deviation | Standard deviation mg/dL during each study period. | 6 weeks | 
| CGM metrics for time in range by time of day | CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM) for each study period. | 6 weeks | 
| Time to intervention for study meal challenges | Number of minutes until additional treatment given during study meal challenges for each study period. | 6 weeks | 
| Number of interventions for study meal challenges | Number of additional treatments given during study meal challenges for each study period. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Control-IQ technology, type 1 diabetes