Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump

Medtronic Diabetes8 sites in 7 countries153 target enrollmentJanuary 2008

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Medtronic Diabetes
Enrollment: 153
Locations: 8
Primary Endpoint: HbA1c at 6 Month
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

July 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Medtronic Diabetes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
•Sub-optimal glycemic control (7.5%\<HbA1c\<9.5%).
•Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
•Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
•Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria

•Existing pregnancy or intention to conceive (as assessed by investigator).
•Hearing or vision impairment so that glucose display and alarms cannot be recognized.
•Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
•History of hypoglycemic unawareness as assessed by the investigator.
•Alcohol or drug abuse, other than nicotine.
•Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
•Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index \>35 and children Body Mass Index \> 2 standard deviations. for age) as assessed by the investigator.
•Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
•For pediatric subjects: does not have a reliable support person.
•Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).