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:
NCT00629304
Eligibility Criteria:
Inclusion Criteria:
* type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
* age \> 18 y.o.
* intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
* chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion
Exclusion Criteria:
* patient with unstable associated evolutive pathology
* patient who need a more frequent diabetic follow up (than in the protocol)
* patient with a education teaching within the 3 months before inclusion
* patient with a hemoglobinopathy
* patient with toxicomania, alcoholism or psychological troubles
* type 2 diabetes patients
* patient who don't need strict metabolic objectives
* pregnant or parturient women
* person with no freedom (prisoner)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00629304
Study Brief:
Protocol Section:
NCT00629304