Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02892604
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02892604
Study Brief:
Protocol Section:
NCT02892604