SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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). Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off/On<br>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] | Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)<br>* 6 months of pump plus continuous glucose sensing in conjunction to SMBG<br>* Other names: Medtronic MMT-522 or MMT-722 + MMT7707WW;|
| Experimental: On/Off<br>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] | Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)<br>* insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.<br>* Other names: MMT-522 or MMT-722 + MMT7707WW + CSS7100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 6 Month | The end of period difference in HbA1c after 6 months of treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Variability | 24 h SD of glucose values (mg/dl) | 6 months | 
| Number of Severe Hypoglycemia Events |  | 6 months | 
| Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l) |  | 6 months | 
| Postprandial Glycaemia | Breakfast Postprandial glycaemia | 6 months | 
| Pediatric Quality of Life Inventory (Vers 4.0; PedsQL) | 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 | 6 months | 
| Diabetic Ketoacidosis Events | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes