Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes

Study Overview
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Brief Summary
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A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

Official Title
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Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: insulin pump to inControl AP platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year Treatment by insulin pump since at least 6 months Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start Agreement on stopping closed-loop insulin delivery after acetaminophen use and 4 following hours Agreement on suspending use of patient CGM device during the study period while study CGM will be used Access to the internet and a mobile phone network at home Agreement on following study procedures Affiliation to the French social security system or a similar healthcare coverage system Mandatory written informed consent Exclusion Criteria: Need for chronic use of acetaminophen Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion Hemophilia or other coagulation disorders Psychological and/or cognitive troubles which may impair the appropriate following of study procedures Diabetic ketoacidosis during the last 6 months Acute cardiovascular event during the last 12 months Severe hypoglycaemia with convulsions or loss of conscience during the last 12 months Use of a therapy with significant impact on glucose metabolism Cystic fibrosis Lack of nearby third-party assistance availability in case of troubles Malignant disease, except if considered as cured since at least 10 years Impaired kidney function (serum creatinin > 150 umol/L) Impaired liver status (ALAT or ASAT > 2-times upper normal limit) Active gastroparesis Acute adrenocortical event Alcohol or narcotics abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: insulin delivery driven by inControl<br>Closed-loop insulin delivery using inControl AP system is assessed for two weeks, 24/7. Connection of continuous glucose monitoring (CGM) system and insulin pump to inControl AP platform, all wireless and wearable, in free-life conditions Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data. | Device: insulin pump to inControl AP platform<br>* Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time of active insulin closed-loop delivery | Percent time while AP system is active permanently | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time with blood glucose in target range | Percent time while blood glucose is kept in safe 70-180 mg/dl range | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, artificial pancreas, closed-loop insulin infusion