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

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ClinicalTrials.gov Identifier: NCT00211510
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : April 29, 2011
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Device: Paradigm 722 sensor augmented pump Device: Paradigm 715 insulin pump

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Primary Completion Date : August 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

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
Device: Paradigm 722 sensor augmented pump
Subjects use the Paradigm 722 sensor augmented pump
Other Name: 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
Device: Paradigm 715 insulin pump
Subjects use the Paradigm 715 insulin pump
Other Name: 715 pump


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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).

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211510


Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Stanford University
Stanford, California, United States, 94305
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, New York
The Endocrine Group
Albany, New York, United States, 12206
United States, Texas
Diabetes and Glandular Diabetes Research Associates
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Study Director: Scott W Lee, MD Medtronic
More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00211510     History of Changes
Other Study ID Numbers: CEP 178/Z25/A2
First Posted: September 21, 2005    Key Record Dates
Results First Posted: April 29, 2011
Last Update Posted: June 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Medtronic Diabetes:
Diabetes
Continuous Glucose Monitoring
Glycemic Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs