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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT02892604

Collaborator

MEDBIOMED, Montpellier, France (Other), Jaeb Center for Health Research (Other), University of Virginia (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Device: insulin pump to inControl AP platform	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 24, 2015

Actual Primary Completion Date :

Jun 24, 2017

Actual Study Completion Date :

Jun 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: insulin delivery driven by inControl 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 Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.

Arm

Intervention/Treatment

Experimental: insulin delivery driven by inControl

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

Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.

Outcome Measures

Primary Outcome Measures

Percent time of active insulin closed-loop delivery [2 weeks]
Percent time while AP system is active permanently

Secondary Outcome Measures

Percent time with blood glucose in target range [2 weeks]
Percent time while blood glucose is kept in safe 70-180 mg/dl range

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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