SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
- Registration Number
- NCT00598663
- Lead Sponsor
- Medtronic Diabetes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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.
- 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).
- Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Off/On insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\] 4 month wash out period 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\] On/Off insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\] 4 month wash out period 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
- Primary Outcome Measures
Name Time Method HbA1c at 6 Month 6 months The end of period difference in HbA1c after 6 months of treatment
- Secondary Outcome Measures
Name Time Method Number of Severe Hypoglycemia Events 6 months Postprandial Glycaemia 6 months Breakfast Postprandial glycaemia
Diabetic Ketoacidosis Events 6 months A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose \>250 mg/dL) with either low serum bicarbonate (\<15 mEq/L) and/or low pH (\<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.
Glycemic Variability 6 months 24 h SD of glucose values (mg/dl)
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l) 6 months Pediatric Quality of Life Inventory (Vers 4.0; PedsQL) 6 months This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).
Scores are transformed on a scale from 0 to 100. higher values represent a better outcome
Trial Locations
- Locations (8)
Glostrup Hospital
🇩🇰Glostrup, Denmark
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Steno Diabetes Center
🇩🇰Copenhagen, Denmark
Hospital Hietzing
🇦🇹Vienna, Austria
Center Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
University Children's Hospital
🇸🇮Ljubljana, Slovenia
Hospital Clinic i Universitari
🇪🇸Barcelona, Spain
Clinica Pediatrica, Policlinico Umberto I
🇮🇹Rome, Italy