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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT03544892
Eligibility Criteria:
Inclusion Criteria:
* Confirmed Type 1 diabetes for \> 1 year confirmed by physician diagnosis
* HbA1c \>5.9% and \<10%;
* Confirmation of minimum three blood glucose tests per day (meter download or chart record)
* Use of continuous subcutaneous insulin infusion therapy (CSII) or multiple daily injection (MDI) intensive insulin therapy
* No change in insulin therapy type (CSII or MDI) in last 2 months or longer
* Willingness to count carbohydrate and use bolus calculator on insulin pump during the intervention periods
* Willingness to wear a 7 day CGM at three different time points during the study
Exclusion Criteria:
* Females of childbearing potential who are pregnant or intend to become pregnant, are exclusively breastfeeding, or who are not using adequate contraceptive methods
* Use of corticosteroids during or within 30 days prior to the intervention periods
* Macroalbuminuria
* Active proliferative retinopathy combined with an HbA1c ≥ 9%
* Known or suspected alcohol or drug abuse
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT03544892
Study Brief:
Protocol Section:
NCT03544892