Status:
COMPLETED
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-70 years
Phase:
NA
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 Outc...
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 analo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00417989
Start Date
January 1 2007
End Date
June 1 2010
Last Update
May 23 2018
Active Locations (30)
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1
Scripps Institute
La Jolla, California, United States, 92037
2
Children's Hospital of Orange County (CHOC)
Orange, California, United States, 92864-3874
3
Barbara Davis Center, University of Colorado
Boulder, Colorado, United States, 80045
4
Yale University
New Haven, Connecticut, United States, 06522