Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Study Overview
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Brief Summary
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Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

Detailed Description
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This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.

Official Title
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Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects ≥ age 18 years Clinical diagnosis of type 1 diabetes for at least one year Using a basal/bolus regimen by injection (MDI therapy) Total daily dose ≥10 units/day Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump. A1c ≥ 7.5% and ≤ 11% at screening Not pregnant or planning a pregnancy during the time period of the study. Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) Willingness to follow study procedures and a signed informed consent form Exclusion Criteria: Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months Two or more episodes of diabetic ketoacidosis in the past 6 months 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 Significant chronic kidney disease or hemodialysis Significant liver disease History of adrenal insufficiency Hypothyroidism or hyperthyroidism that is not appropriately treated Other chronic disease/condition determined by investigator to interfere with participation in the study Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump Subject is pregnant or lactating or intending to become pregnant before or during participation in this study Investigator judgement that subject would not be able to complete the trial

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates<br>After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use. | Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm<br>* All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Hypoglycemic Events | Number of severe hypoglycemic events (needing assistance) compared to expected incidence | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of time 70-180 mg/dL | CGM percent time 70-180 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Percent of time <54 mg/dL | CGM percent time <54 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Percent of time <70 mg/dL | CGM percent time <70 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Percent of time >180 mg/dL | CGM percent time >180 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Percent of time >250 mg/dL | CGM percent time >250 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Percent of time 70-140 mg/dL | CGM percent time 70-140 mg/dL, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Postprandial glycemic peak mg/dL | Peak CGM glucose after meals, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| 4-Hour post meal glucose AUC | 4-Hour post meal glucose AUC, cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| Sensor glucose median and interquartile range mg/dL | Sensor glucose median and interquartile range , cumulatively as well as after each settings adaptation, as well as compared to 2 weeks of baseline data collection | 15 weeks | 
| CGM Metrics by time of day | Calculate all CGM metrics listed above for: all 24 hours of the day, daytime only, and nighttime only | 15 weeks | 
| Serious Adverse Events | Number of Serious Adverse Events | 15 weeks | 
| Adverse Device Effects | Number of Adverse Device Effects | 15 weeks | 
| Change in total daily insulin use, basal and bolus | Changes in units/day insulin use, for both basal and bolus insulin | 13 weeks | 
| Physician overrides/physician initiated changes in pump settings | Number of physician overrides/physician initiated changes in pump settings | 13 weeks | 
| Patient Reported Outcomes | Score on Diabetes Impact and Device Satisfaction Scale | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery