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

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Predictive Low Glucose Minimizer

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Samsum Diabetes Reserach Inst.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: type 1 diabetes; Predictive Low Glucose Minimizer (PLGM) System

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.; Other Names: type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Animas Corporation
• Investigators: Principal Investigator: Howard Zisser, MD, Samsum Diabetes Reserach Inst.

Publications and helpful links

General Publications

• Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Insulin Pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: 3108873,