At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes mellitus per American Diabetes Association definition
- ✓HbA1c ≥7.5%
- ✓Intensive insulin treatment for at least 3 months
- ✓Physical and intellectual ability to operate Medtronic MiniMed Implantable Pump system
- ✕Daily insulin requirement >66 units/day
- ✕Severe complications including advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease with episode in last 6 months
- ✕Pregnancy, childbearing potential without contraception, or lactating (unless surgically sterile or using approved contraceptives)
- ✕Reside at or plan to travel to elevations >8000 feet during study (commercial airline travel acceptable)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Active Control, Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia
In Brief
A Phase 3 clinical trial evaluating Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 107 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
Study Details
Timeline
Interventions
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.