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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Hypoglycemia-Hyperglycemia Minimizer System

• Registration Number: NCT01401751
• Lead Sponsor: Animas Corporation

Brief Summary

The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) 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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.

Study Timeline

• Study Start: 2011-07-01
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2011-11-01
• Study Completion: 2011-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age 21-65 years
• Type 1 diabetes mellitus for at least one year
• 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

Other Inclusion/Exclusion criteria apply.

Please contact clinical study site for complete details.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Hypoglycemia-Hyperglycemia Minimizer System	non-randomized, uncontrolled, feasibility study

Primary Outcome Measures

Name	Time	Method
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.	End of Study - in approximately 5 months from first subject enrolled	Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.

Secondary Outcome Measures

Name	Time	Method
Safety Evaluation	End of Study - in approximately 5 months from first subject enrolled	Measuring the following: * the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions; * Resulting glucose data from 24 hour clinical research center visit

Trial Locations

Locations (1)

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States