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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02271594
Eligibility Criteria:
Inclusion Criteria:
1. Patients with DM1 or DM2, diagnosed for more than a year from the time of inclusion
2. Age between 18 and 75 years old, inclusive
3. Treatment by insulin injection using pen injector for at least 1 year - concomitant oral therapy or GLP-1 injections are allowed
4. Self-care (patients must be giving injections to themselves as opposed to getting them by third parties)
5. Presence of LH on structured physical exam (if in doubt, the patient will not be included)
6. Injections performed frequently into the LH (at least once per day)
7. Self-monitoring of blood glucose (SMBG) and willingness to bring meter to every visit for electronic download
8. Willingness to fill out a diary recording any adverse event (e.g. hypoglycaemia, ambulance call out, unscheduled visit to health care facility) or symptoms that occur during the study
9. Ability so speak and read English or accompanied by a person who can competently translate for the patient
Exclusion Criteria:
1. Pregnancy (declarative)
2. Ongoing participation in another clinical trial
3. Conditions other than diabetes treatment which might cause lipodystrophies (ex: antiretroviral therapy)
4. Medical conditions that may, in the opinion of the PI, influence study results (ex: currently active cancer, uncontrolled endocrine disorder, eating disorders)
5. Current treatments that may, in the opinion of the PI, influence study results (ex: long-term corticosteroids)
6. Other injectable treatment in diabetes (with the exception of GLP-1) such as insulin pumps, syringes
7. Study staff will document the reasons for the exclusion, if any.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02271594
Study Brief:
Protocol Section:
NCT02271594