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Type 1 DiabetesSTAR3NCT00417989

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

A study testing MiniMed Paradigm REAL-Time System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 7 to 70 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
MiniMed Paradigm REAL-Time System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
485 participants
Where
30 sitesin 2 countries
Study dates
Jan 2007to Jun 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States26 sites

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28801

  • Joslin Clinic

    Boston, Massachusetts, 02215

  • Barbara Davis Center, University of Colorado

    Boulder, Colorado, 80045

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University Medical Center Diabetes Research Clinic

    Durham, North Carolina, 27710

  • DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Diabetes and Obesity Center, East Carolina University

    Greenville, North Carolina, 27834

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Scripps Institute

    La Jolla, California, 92037

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • University of Wisconsin Health West

    Madison, Wisconsin, 53717

  • Diabetes Research Institute (DRI)

    Miami, Florida, 33136

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06522

  • Children's Hospital of Orange County (CHOC)

    Orange, California, 92864-3874

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14644

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Minnesota International Diabetes Center

    Saint Louis Park, Minnesota, 55416

  • Children's Hospital of St. Paul

    Saint Paul, Minnesota, 55102

  • Utah Diabetes Center

    Salt Lake City, Utah, 84108

  • Washington University

    St Louis, Missouri, 63110

  • Mid-America Diabetes Associates

    Wichita, Kansas, 67211

Other trials in United States

Canada4 sites

  • Kingston General Hospital

    Kingston, Ontario, K7M5L2

  • Health Science Center Memorial Hospital of Newfoundland

    St. John's, Newfoundland and Labrador, A1B3V6

  • Toronto General Hospital - UHN

    Toronto, Ontario, M5G 2C4

  • Endocrine Research, Inc.

    Vancouver, British Columbia, V6E1M7

Other trials in Canada

About this study

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

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)

Read the 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).

Conditions
Type 1 Diabetes
Being tested
MiniMed Paradigm REAL-Time System
Keywords
Glycemic control, Sensor
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed Paradigm REAL-Time SystemDevice

    Also called Medtronic Paradigm REAL-Time System

    Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter

Study groups in NCT00417989
Study groupRoleWhat they receive
722 sensor augmented pumpExperimental722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Receives: Device: MiniMed Paradigm REAL-Time System
Multiple Daily Injections (MDI)No interventionMDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 52 weeks

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and 52 weeks

  2. 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.

    Measured: Baseline and 52 weeks

  3. 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.

    Measured: Baseline and 52 weeks

  4. 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.

    Measured: Baseline and 52 weeks

  5. 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.

    Measured: Baseline and 52 weeks

  6. 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

    Measured: Baseline and 52 weeks

  7. 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.

    Measured: Baseline and 52 Weeks

  8. 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.

    Measured: Baseline and 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417989
Sponsor's protocol ID
CEP179/Z25
Acronym
STAR3
Status last verified
May 2018
First submitted
2 Jan 2007
Last updated
23 May 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25175313

  • 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.

    PubMed 20587585

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed Paradigm REAL-Time System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in A1c From Baseline to 52 Weeks (time frame: Baseline and 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00417989, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.

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