Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 10/3/2013 |
| Start Date: | July 2013 |
| End Date: | October 2013 |
| Contact: | Brian Levy, MD |
| Email: | blevy1@its.jnj.com |
| Phone: | 610 889-4447 |
Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type
1 diabetes that are currently using an insulin pump.
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people
with type 1 diabetes who are currently using an insulin pump. During the subject's
participation, the study staff will closely monitor the study subject in a clinical research
center environment for approximately 30 hours, while controller algorithm determined insulin
doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Inclusion Criteria:
- Age 21-65 years
- Type 1 diabetes mellitus for at least one year
- Currently using an insulin infusion pump for at least the past 6 months
Exclusion Criteria:
- Pregnancy
- History of Diabetic Ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
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