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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401751
• Other study ID #: 3076823
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: July 28, 2017
• Start date: July 1, 2011
• Est. completion date: December 1, 2011

Study information

• Verified date: July 2017
• Source: Animas Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1, 2011
• Est. primary completion date: November 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Summary of Key inclusion/exclusion criteria:

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Device:
• Hypoglycemia-Hyperglycemia Minimizer System
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Animas Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.	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.	End of Study - in approximately 5 months from first subject enrolled
Secondary	Safety Evaluation	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	End of Study - in approximately 5 months from first subject enrolled