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Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (STAR3)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MiniMed Paradigm REAL-Time System
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Glycemic control, Sensor

Eligibility Criteria

7 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 7 to 70 years
  • Has been treated by the Principal Investigator or referring physician within the same practice for at least six months prior to screening
  • Is fluent in speaking, reading and understanding English
  • Has Type 1 diabetes mellitus, diagnosed by c-peptide, insulin antibodies, or prior documented DKA, or by a clinical picture consistent with Type 1 diabetes and excluding type 2 diabetes i.e. - previous ketosis as evidenced by laboratory evidence of urine ketones or alteration in bicarbonate levels with corresponding increased glucose levels, diagnosed at least 6 months prior to study entry, or has a fasting C-peptide that meet criteria of 110% of lower limit of normal or 200% of lower limit of normal in the presence of renal insufficiency (creatinine clearance < 50ml/min) at screening
  • Is insulin infusion pump naїve or has not used an insulin pump within the last three years
  • Currently is treated with insulin administration by injection > (greater or equal to) three (3) times daily and therapy has included the use of a long acting analog insulin for at least the previous 3 months prior to screening
  • Performs fingerstick blood glucose (BG) testing an average of four times per day in the 30 days prior to screening
  • Within 6 months prior to study entry and at Screening Visit 1, subject has a documented A1c level =/> 7.4% and =/< 9.5%

Exclusion Criteria:

  • Is pregnant or planning to become pregnant during the course of the study
  • Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months
  • Currently using oral or injectable steroids or immunosuppressant medications
  • Use of any other pharmaceutical agent, other than insulin to treat diabetes, within the three months prior to screening;
  • Has a current history of alcohol or drug abuse
  • Has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease in the 3 months prior to screening
  • Has uncontrolled hypertension (diastolic blood pressure >100 mmHg and/or sustained systolic level [3 successive readings] > 160). Subjects who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening
  • Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
  • Is undergoing renal dialysis, including hemodialysis and continuous ambulatory peritoneal dialysis (CAPD)
  • Has evidence of any allergic dermatological condition (e.g., severe adhesive sensitivity)
  • Has recurrent episodes of skin infections or history of staphylococcus infection carrier state
  • Has potential for lack of compliance or any other issue that may preclude the subject from satisfactory participation in the study, based on Investigatory judgment

Sites / Locations

  • Scripps Institute
  • Children's Hospital of Orange County (CHOC)
  • Barbara Davis Center, University of Colorado
  • Yale University
  • Diabetes Research Institute (DRI)
  • Endocrine Research Solutions, Inc.
  • Rocky Mountain Diabetes and Osteoporosis Center
  • Mid-America Diabetes Associates
  • Kentucky Diabetes Endocrinology Center
  • Joslin Clinic
  • DeVos Children's Hospital
  • Mayo Clinic
  • Minnesota International Diabetes Center
  • Children's Hospital of St. Paul
  • Washington University
  • University of Rochester
  • Mountain Diabetes & Endocrine Center
  • University of North Carolina at Chapel Hill
  • Duke University Medical Center Diabetes Research Clinic
  • Diabetes and Obesity Center, East Carolina University
  • Ohio State University
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia
  • Vanderbilt University
  • Utah Diabetes Center
  • University of Wisconsin Health West
  • Endocrine Research, Inc.
  • Health Science Center Memorial Hospital of Newfoundland
  • Kingston General Hospital
  • Toronto General Hospital - UHN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

722 sensor augmented pump

Multiple Daily Injections (MDI)

Arm Description

722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year

MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year

Outcomes

Primary Outcome Measures

Change in A1c From Baseline to 52 Weeks
Change is defined as A1c at Week 52 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

Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.
Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;
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 52.
Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52
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 52.
Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score
Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Health Economic Outcome
Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed
Quality of Life - Short Form-36 (SF-36v2™), General Health
Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy
Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.

Full Information

First Posted
January 2, 2007
Last Updated
May 22, 2018
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT00417989
Brief Title
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Acronym
STAR3
Official Title
The STAR 3 Study - A Prospective, Randomized, Two-Arm Study to Compare the Efficacy of the MiniMed Paradigm REAL-Time System Versus Multiple Daily Injections (MDI) in Subjects Naïve to Insulin Pump Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group". Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)
Detailed Description
Glycemic control remains a significant challenge for adult, adolescent and pediatric Type 1 diabetics. The current first line standard of care continues to be MDI therapy utilizing a long acting analog insulin. 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 future therapy change recommendations. The MiniMed Paradigm REAL-Time 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. Additionally, data can be downloaded from the monitor to a personal computer, using appropriate software, so that the patient and physician can see a complete picture of glucose trends over time. The System will also alert users of high and low glucose levels, and allow subjects and their clinicians to treat to a therapeutic target HbA1c under carefully monitored conditions. Subjects wearing the MiniMed Paradigm REAL-Time System will be compared to subjects that continue on their current MDI therapy, that includes a long acting analog insulin, over a 12 month period to evaluate changes in glycemic control (HbA1c).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Glycemic control, Sensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
722 sensor augmented pump
Arm Type
Experimental
Arm Description
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Arm Title
Multiple Daily Injections (MDI)
Arm Type
No Intervention
Arm Description
MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year
Intervention Type
Device
Intervention Name(s)
MiniMed Paradigm REAL-Time System
Other Intervention Name(s)
Medtronic Paradigm REAL-Time System
Intervention Description
Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter
Primary Outcome Measure Information:
Title
Change in A1c From Baseline to 52 Weeks
Description
Change is defined as A1c at Week 52 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.
Time Frame
Baseline and 52 weeks
Secondary Outcome Measure Information:
Title
Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;
Description
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.
Time Frame
Baseline and 52 weeks
Title
Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52
Description
Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.
Time Frame
Baseline and 52 weeks
Title
Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;
Description
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 52.
Time Frame
Baseline and 52 weeks
Title
Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52
Description
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 52.
Time Frame
Baseline and 52 weeks
Title
Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score
Description
Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame
Baseline and 52 weeks
Title
Health Economic Outcome
Description
Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed
Time Frame
Baseline and 52 weeks
Title
Quality of Life - Short Form-36 (SF-36v2™), General Health
Description
Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame
Baseline and 52 Weeks
Title
Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy
Description
Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame
Baseline and 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 7 to 70 years Has been treated by the Principal Investigator or referring physician within the same practice for at least six months prior to screening Is fluent in speaking, reading and understanding English Has Type 1 diabetes mellitus, diagnosed by c-peptide, insulin antibodies, or prior documented DKA, or by a clinical picture consistent with Type 1 diabetes and excluding type 2 diabetes i.e. - previous ketosis as evidenced by laboratory evidence of urine ketones or alteration in bicarbonate levels with corresponding increased glucose levels, diagnosed at least 6 months prior to study entry, or has a fasting C-peptide that meet criteria of 110% of lower limit of normal or 200% of lower limit of normal in the presence of renal insufficiency (creatinine clearance < 50ml/min) at screening Is insulin infusion pump naїve or has not used an insulin pump within the last three years Currently is treated with insulin administration by injection > (greater or equal to) three (3) times daily and therapy has included the use of a long acting analog insulin for at least the previous 3 months prior to screening Performs fingerstick blood glucose (BG) testing an average of four times per day in the 30 days prior to screening Within 6 months prior to study entry and at Screening Visit 1, subject has a documented A1c level =/> 7.4% and =/< 9.5% Exclusion Criteria: Is pregnant or planning to become pregnant during the course of the study Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months Currently using oral or injectable steroids or immunosuppressant medications Use of any other pharmaceutical agent, other than insulin to treat diabetes, within the three months prior to screening; Has a current history of alcohol or drug abuse Has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease in the 3 months prior to screening Has uncontrolled hypertension (diastolic blood pressure >100 mmHg and/or sustained systolic level [3 successive readings] > 160). Subjects who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study Is undergoing renal dialysis, including hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) Has evidence of any allergic dermatological condition (e.g., severe adhesive sensitivity) Has recurrent episodes of skin infections or history of staphylococcus infection carrier state Has potential for lack of compliance or any other issue that may preclude the subject from satisfactory participation in the study, based on Investigatory judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N Davis, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William V Tamborlane, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott W Lee, MD
Organizational Affiliation
Medtronic Minimed
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Children's Hospital of Orange County (CHOC)
City
Orange
State/Province
California
ZIP/Postal Code
92864-3874
Country
United States
Facility Name
Barbara Davis Center, University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06522
Country
United States
Facility Name
Diabetes Research Institute (DRI)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Mid-America Diabetes Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
Kentucky Diabetes Endocrinology Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Joslin Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Minnesota International Diabetes Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Children's Hospital of St. Paul
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14644
Country
United States
Facility Name
Mountain Diabetes & Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center Diabetes Research Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Diabetes and Obesity Center, East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Utah Diabetes Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Wisconsin Health West
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Endocrine Research, Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E1M7
Country
Canada
Facility Name
Health Science Center Memorial Hospital of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7M5L2
Country
Canada
Facility Name
Toronto General Hospital - UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25175313
Citation
Perkins BA, Halpern EM, Orszag A, Weisman A, Houlden RL, Bergenstal RM, Joyce C. Sensor-augmented pump and multiple daily injection therapy in the United States and Canada: post-hoc analysis of a randomized controlled trial. Can J Diabetes. 2015 Feb;39(1):50-4. doi: 10.1016/j.jcjd.2014.03.003. Epub 2014 Aug 29.
Results Reference
derived
PubMed Identifier
20587585
Citation
Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. doi: 10.1056/NEJMoa1002853. Epub 2010 Jun 29. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092.
Results Reference
derived

Learn more about this trial

Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy

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