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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00460304
Eligibility Criteria:
Inclusion Criteria:
* Age: \>17
* Type I diabetes
* Onset of diabetes \>3 months
* Use of insulin pump \>3 months
* Hb A1C \<8.9%
* Demonstrated compliance to clinic visits
* Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter
* Monitor blood glucose \>4/day
Exclusion Criteria:
* Pregnancy or nursing
* Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.
* Renal failure (creatinine \>1.5 mg/dl
* Symptomatic gastroparesis
* Using a medication that would interfere with insulin sensitivity
* Treatment with extenatide or DPP IV inhibitor within the last 4 weeks
* HbA1C change \>0.9 % within the last 3 months
* Significant change in eating or activity pattern
* Weight change of \>1.9 kg within the last 3 months
* ALT \>3 times upper limits of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00460304
Study Brief:
Protocol Section:
NCT00460304