Android Artificial Pancreas System (Android APS) Versus Control-IQ

Study Overview
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Brief Summary
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The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.

Official Title
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Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Insulin Pump t:slim X2 with Control-IQ technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed >2 years ≥ 18 years old written informed consent prior to starting study related activity previous user of AndroidAPS at least for 3 months Exclusion Criteria: severe noncompliance lactation, pregnancy, intending to become pregnant during study use of medication with effects on carbohydrate metabolism

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AndroidAPS versus Control-IQ<br>Patients with use of the Control-IQ system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system) | Device: Insulin Pump t:slim X2 with Control-IQ technology<br>* Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS<br>* Other names: Continuous Glucose Monitoring Dexcom G6 system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in target ranges | 3.9-10.0 mmol/L (70-180 mg/dl) | Up to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in hypoglycemic ranges | <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl) | Up to 28 weeks | 
| Percentage of time in hyperglycemic ranges | >10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl) | Up to 28 weeks | 
| Changes in glycemic variability | Expressed as the coefficient of variation | Up to 28 weeks | 
| Incidence of severe hypoglycaemia | Requiring third-party assistance to treat | Up to 28 weeks | 
| Changes in glycated haemoglobin (HbA1c) | Differences between HbA1c values in the initial period and after follow-up | Up to 28 weeks | 
| Hypoglycemia Attitudes and Behavior Scale (HABS) | This validated questionnaire contains in total 14 questions that highlights two critical dimensions of hypoglycemia-related concerns (anxiety and avoidance) and one positive dimension (confidence). 14 items use Likert scales from 1 to 5, total score from 14 to 70, the higher total score means worse outcome. | Up to 28 weeks | 
| Diabetes Distress Scale (DDS) | This validated questionnaire assess diabetes-related emotional stress. This 17-item tool uses the Likert scales from 1 to 6. Total score is from 17 to 102, while higher total score means worse outcome. | Up to 28 weeks | 
| The 5-item World Health Organization well-being index (WHO-5 index) | This validated questionnaire contains in total 5 questions with Likert scales from 5 to 0. Total score is multiplied by 4 to give a final score ranging from 0 to 100, higher score denote higher quality of life (better outcome). | Up to 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitoring, Insulin Pump, Closed-loop hybrid system