Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919385
• Other study ID #: 3108873,
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2013
• Last updated: September 17, 2013
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Animas Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Device:
• Predictive Low Glucose Minimizer
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators 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.

Locations

Country	Name	City	State
United States	Samsum Diabetes Reserach Inst.	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	Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting	Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold.; Ability of the system to issue timely and accurate warnings.	1 week after subject is enrolled in the study	Yes
Secondary	Capturing the number of Adverse Events as a measure of assessing subject safety	Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.	1 week after subject is enrolled in the study	Yes