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

NCT02892604 | Terminated DMC

• 1 other identifier: 9722
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; artificial pancreas; closed-loop insulin infusion

Outcome Measures

Primary Outcomes (1)

• Percent time of active insulin closed-loop delivery

  Percent time while AP system is active permanently

  2 weeks

Secondary Outcomes (1)

• Percent time with blood glucose in target range

  2 weeks

Study Arms (1)

insulin delivery driven by inControl

EXPERIMENTAL

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

Interventions

insulin pump to inControl AP platform DEVICE

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

insulin delivery driven by inControl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Need for chronic use of acetaminophen
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• MEDBIOMED, Montpellier, France: collaborator
• Jaeb Center for Health Research: collaborator
• University of Virginia: collaborator

Study Sites (1)

UHMontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric M RENARD, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: November 24, 2015
• Primary Completion: June 24, 2017
• Study Completion: June 24, 2017
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

FR (1)