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

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
insulin pump to inControl AP platform
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, artificial pancreas, closed-loop insulin infusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UHMontpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

insulin delivery driven by inControl

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent time of active insulin closed-loop delivery
Percent time while AP system is active permanently

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2016
Last Updated
December 8, 2021
Sponsor
University Hospital, Montpellier
Collaborators
MEDBIOMED, Montpellier, France, Jaeb Center for Health Research, University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02892604
Brief Title
Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes
Acronym
IDCLTraining
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
not enough participants
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
June 24, 2017 (Actual)
Study Completion Date
June 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
MEDBIOMED, Montpellier, France, Jaeb Center for Health Research, University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, artificial pancreas, closed-loop insulin infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin delivery driven by inControl
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
insulin pump to inControl AP platform
Intervention Description
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
Primary Outcome Measure Information:
Title
Percent time of active insulin closed-loop delivery
Description
Percent time while AP system is active permanently
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Percent time with blood glucose in target range
Description
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M RENARD, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
UHMontpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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