Control-IQ Technology in Individuals With Type 2 Diabetes

Study Overview
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Brief Summary
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A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.

Detailed Description
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The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.

Official Title
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Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)

Conditions
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Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Device: Control-IQ technology 1.5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and residing in the US Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ technology) Total daily insulin dose ≤200 units/day Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. HbA1c ≥ 7.5% and ≤ 12% at screening Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study Has the ability to read and understand written English Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study. Exclusion Criteria: Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months History of inpatient psychiatric treatment in the past 6 months History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study. History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in the protocol or determined by investigator to interfere with the study Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication specifically listed in the protocol, or starting a new glucose lowering agent during the trial. Unstable dose of any medication used for weight loss, as listed in the protocol, or starting a new medication for weight loss during the trial. Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (>450 ms) History of hemodialysis History of adrenal insufficiency Uncontrolled hypo- or hyperthyroidism Significant diabetes related complications, based on investigator assessment Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, prospective clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal Insulin Only (Group A)<br>2 to 4 week CGM run-in 2 to 4 week pump run-in 6 weeks Control-IQ technology use | Device: Control-IQ technology 1.5<br>* All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.<br>|
| Experimental: Multiple Daily Injections (Group B)<br>2 to 4 week CGM run-in 2 to 4 week pump run-in 6 weeks Control-IQ technology use | Device: Control-IQ technology 1.5<br>* All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM Time Below 54 mg/dL (Non-Inferiority) | CGM-measured percentage below 54 mg/dl, non-inferiority compared to baseline | 6 weeks | 
| CGM Time Above 180 mg/dL | CGM-measured percentage above 180 mg/dl, compared to baseline | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM Time In Range 70-180 mg/dL | CGM-measured percentage in range 70-180 mg/dl, compared to baseline | 6 weeks | 
| CGM Time Below 70 mg/dL | CGM-measured percentage below 70 mg/dl, compared to baseline | 6 weeks | 
| CGM Time Above 250 mg/dL | CGM-measured percentage above 250 mg/dl, compared to baseline | 6 weeks | 
| CGM Time In Range 70-140 mg/dL | CGM-measured percentage in range 70-140 mg/dl, compared to baseline | 6 weeks | 
| Post-prandial glycemic peak mg/dL | Post-prandial glycemic peak (up to 4 hours) after breakfast, lunch, and dinner | 6 weeks | 
| 4-hour post meal glucose AUC | 4-hour post meal glucose AUC | 6 weeks | 
| CGM mean glucose mg/dL | CGM measured mean glucose mg/dL, compared to baseline | 6 weeks | 
| Coefficient of variation (CV) | CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline | 6 weeks | 
| Standard Deviation (SD) | CGM measured glucose variability measured with the standard deviation (SD), compared to baseline | 6 weeks | 
| CGM metrics by time of day | Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM), compared to baseline. | 6 weeks | 
| CGM metrics during and immediately after the exercise challenges (2 hours afterwards included) | Calculate all CGM metrics and adverse event rates during and immediately after the scheduled exercise sessions (to 2 hours after exercise). These metrics related to exercise will be analyzed separately and excluded from the main analysis. | 6 weeks | 
| CGM metrics overnight after the challenges | Calculate all CGM metrics and adverse event rates overnight after the challenges. These metrics related to exercise will be analyzed separately and excluded from the main analysis. | 6 weeks | 
| Total daily insulin use (units/day) | Total daily insulin use (units/day), compared to baseline | 6 weeks | 
| Total basal insulin (units/day) | Total basal insulin (units/day), compared to baseline | 6 weeks | 
| Total bolus insulin (units/day) | Total bolus insulin (units/day), compared to baseline | 6 weeks | 
| Weight (kg) | Change in weight (kg) over the course of the study | 6 weeks | 
| Body Mass Index | Change in body mass index (kg/m2) over the course of the study | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, Control-IQ technology, automated insulin dosing, automated insulin delivery