Randomised, cross-over, controlled, multi-centric study to assess whether type 1 diabetic patients in sub-optimal glycaemic control can improve using the continuous glucose values of the MiniMed Paradigm REAL-Time Insulin Pump system versus the MiniMed Paradigm Insulin Pump

Medtronic International Trading Sarl (Switzerland)0 sites160 target enrollmentJanuary 23, 2008

ConditionsType 1 diabetes mellitus Nutritional, Metabolic, Endocrine

Overview

Phase: 未知
Intervention: Not specified
Conditions: Type 1 diabetes mellitus
Sponsor: Medtronic International Trading Sarl (Switzerland)
Enrollment: 160
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22965294 [added 28/02/2019]

Registry

who.int

Start Date

January 23, 2008

End Date

July 1, 2010

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Medtronic International Trading Sarl (Switzerland)

Eligibility Criteria

Inclusion Criteria

•1\. Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent
•2\. Patients aged 6 years to 70 years old, both male and female
•3\. Sub\-optimal glycaemic control (7\.5% less than HbA1c less than 9\.5%)
•4\. Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent
•5\. Patient treated within the practice of the investigator's centre at least 6 months prior to signature of informed consent
•6\. Patient has no preliminary experience with the sensor function of the Paradigm Real\-Time (PRT)® or the Guardian® REAL\-Time for the 4 months prior signature of informed consent

Exclusion Criteria

•1\. Existing pregnancy or intention to conceive (as assessed by investigator)
•2\. Hearing or vision impairment so that glucose display and alarms cannot be recognised
•3\. Three or more incidents in the last 12 months of severe hypoglycaemia with documented blood glucose (BG) below 50 mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar
•4\. History of hypoglycaemic unawareness as assessed by the investigator
•5\. Alcohol or drug abuse, other than nicotine
•6\. Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema, etc.)
•7\. Any documented concomitant chronic disease known to affect diabetes control (e.g., altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Addison's disease) or any concomitant pharmacological treatment that might modify glycaemic values (e.g., chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults: body mass index (BMI) greater than 35 and children BMI greater than 2 s.d. for age) as assessed by the investigator
•8\. 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
•9\. For paediatric subjects: does not have a reliable support person
•10\. Plans to travel for extended periods (3\+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (e.g., exotic countries, remote places)