Clinical trial NCT02892604: Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
artificial pancreas
closed-loop insulin infusion
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: MEDBIOMED, Montpellier, France
name: Jaeb Center for Health Research
name: University of Virginia
First posted: 2016-09-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent time of active insulin closed-loop delivery
timeFrame: 2 weeks
Secondary outcomes:
measure: Percent time with blood glucose in target range
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHMontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric M RENARD, MD, PhD
role: STUDY_DIRECTOR
References: