Type 1 Diabetes Clinical Trial
— RTDOfficial title:
To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
NCT number | NCT00441129 |
Other study ID # | 186 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | May 2008 |
Verified date | December 2018 |
Source | Medtronic Diabetes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.
Status | Completed |
Enrollment | 115 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patient has signed informed consent form prior to study entry. - Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion. - Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion. - Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry. - Have an HbA1c value = 8 %. - Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old. - Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily. - Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (~60 times during the study period ). - Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (~60 times during the study period ). - Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period. - Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days. - Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization. - Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment. Exclusion Criteria: - Hearing or vision impairment so that alarms cannot be recognized. - Alcohol or drug abuses other than nicotine. - Allergy to sensor or components of the sensor. - Allergy to insulin infusion set or components of the insulin infusion set. - Patient is pregnant or of child-bearing potential during the study. - Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol. - Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions. - Patients participating in other device or drug studies will be excluded. - Patients may participate in this study only once. |
Country | Name | City | State |
---|---|---|---|
France | CHU Côte de Nacre | Caen | |
France | Hôpital Universitaire Debrousse | Lyon | |
France | Hôpital Sainte Marguerite | Marseille | |
France | CH La Peyronie | Montpellier | |
France | American Memorial Hospital | Reims | |
France | Hôpital Jeanne D'Arc | Saint-Mandé | |
France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
France | CHU Rangueil | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Medtronic Diabetes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in HbA1C From Baseline and 6 Months | Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline | Baseline and 6 months | |
Secondary | Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings. | Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline | Baseline and 6 months | |
Secondary | Change From Baseline in Total Daily Dose (TDD) | Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline | Baseline and 6 months |
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