Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Hypo-Hyper Minimizer (HHM) System

• Registration Number: NCT01638299
• Lead Sponsor: Animas Corporation

Brief Summary

Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research setting.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-06-25
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-19
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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
• Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypo-Hyper Minimizer (HHM) System	Hypo-Hyper Minimizer (HHM) System	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.	After subject is discharged from CRC, 1 week after enrolment

Secondary Outcome Measures

Name	Time	Method
Number of Safety Events and any additional information that can be used for product development	After subject is discharged from CRC, 1 week after enrolment

Trial Locations

Locations (2)

Samsum Diabetes Reserach Inst.; 🇺🇸 Santa Barbara, California, United States

UVA Diabetes Technology Center; 🇺🇸 Charlottesville, Virginia, United States