Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes (STAR1)

May 10, 2017 updated by: Medtronic Diabetes

Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial

The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.

Study Overview

Detailed Description

Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.

Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

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

    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • New York
      • Albany, New York, United States, 12206
        • The Endocrine Group
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Diabetes Research Associates
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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

10 years to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 12 - 80 years
  • Type 1 Diabetes Mellitus diagnosed at least 1 year ago
  • Using insulin infusion pump for past 6 months minimum
  • Performing minimum 4 blood glucose tests per day
  • Agree to treat to A1c targets
  • Read and understand English

Exclusion Criteria:

  • Pregnant or planning pregnancy
  • History of unresolved tape allergy or skin conditions

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paradigm 722 sensor augmented pump
subjects will use the Paradigm 722 sensor augmented pump for infusion of insulin and continuous glucose monitoring
Subjects use the Paradigm 722 sensor augmented pump
Other Names:
  • 722 pump
Active Comparator: Paradigm 715 insulin pump
subjects will use the Paradigm 715 insulin pump which does not include sensor augmentation for infusion of insulin
Subjects use the Paradigm 715 insulin pump
Other Names:
  • 715 pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in A1c From Baseline to 26 Weeks
Time Frame: Baseline and 26 weeks
Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
Baseline and 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26
Time Frame: Baseline and 26 weeks
Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.
Baseline and 26 weeks
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26
Time Frame: Baseline and 26 weeks
Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26
Baseline and 26 weeks
Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26
Time Frame: Baseline and 26 weeks
Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26
Baseline and 26 weeks
Glucose Sensor Accuracy as Measured in the 722 Group
Time Frame: Baseline and 26 weeks
Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).
Baseline and 26 weeks
Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups
Time Frame: Baseline and 26 weeks
Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.
Baseline and 26 weeks

Collaborators and Investigators

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

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

June 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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