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

September 19, 2012 updated by: Animas Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Samsum Diabetes Reserach Inst.
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Diabetes Technology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hypo-Hyper Minimizer (HHM) System
Device: Hypo-Hyper Minimizer (HHM) System
Adjustment of Insulin dosing during meal time
Other Names:
  • Insulin delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: After subject is discharged from CRC, 1 week after enrolment
After subject is discharged from CRC, 1 week after enrolment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Animas Corporation

Investigators

  • Study Director: Henry Anhalt, DO, Animas Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (ESTIMATE)

July 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2012

Last Update Submitted That Met QC Criteria

September 19, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3076823, V3.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on Hypo-Hyper Minimizer (HHM) System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe