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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01050868
Eligibility Criteria:
Inclusion Criteria:
* Subjects \>/= 18 years at screening
* Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit
* Subjects have to use a fast acting analog insulin
* HbA1c = 9% (measured with DCA 2000)
* Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (\~10 tests per day) with skipped meals and testmeals
* Willing to use the 3 different bolus calculators during the course of the study
* Willing to undergo planned hyperglycemia
* Willing to perform high frequency BG monitoring (\> 20 / day) during the experiment
Exclusion Criteria:
* Type 2 Diabetes
* Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)
* Current addiction to alcohol or substances of abuse
* Pregnant or lactating women
* Any known life-threatening disease
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01050868
Study Brief:
Protocol Section:
NCT01050868