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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00442767
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes only
* Diagnosed with T1DM for at least 1 year
* HbA1C less than or equal to 8.5%
* Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump
* Hemoglobin equal to or greater than 12mg/dL
* Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism
* Negative pregnancy test, in the case of females
Exclusion Criteria:
* Lack of supportive family
* Evidence or history of chemical abuse
* BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age
* Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring
* Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months
* Have hypoglycemia unawareness
* Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
* Pregnant or lactating patients, or patients planning on becoming pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT00442767
Study Brief:
Protocol Section:
NCT00442767