Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes
NCT ID: NCT02892604
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
3 participants
INTERVENTIONAL
2015-11-24
2017-06-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
insulin pump to inControl AP platform
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin pump to inControl AP platform
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MEDBIOMED, Montpellier, France
UNKNOWN
Jaeb Center for Health Research
OTHER
University of Virginia
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric M RENARD, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UHMontpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9722
Identifier Type: -
Identifier Source: org_study_id