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 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT00891995
Eligibility Criteria:
Inclusion Criteria:
* Age 6.0 to \<46.0 years
* Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
* If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
* Willing to accept randomization to either the intensive diabetes management group or the standard care group.
* Willing to complete the planned 2 years of follow-up.
* Able to electronically transmit data monthly.
* Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.
Exclusion Criteria:
* Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
* Currently anemic (hematocrit level will be obtained at the screening visit).
* Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
* Complicating medical issues that might interfere with study conduct.
* Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
* Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
45 Years
Study:
NCT00891995
Study Brief:
Protocol Section:
NCT00891995