Type 1 Diabetes
Conditions
Keywords
Improvement of the blood glucose control
Brief summary
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.
Detailed description
The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients
Interventions
DEVICEMinimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
DEVICEMinimed Paradigm 512/712 Insulin pump
Minimed Paradigm 512/712 Insulin pump
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in HbA1C From Baseline and 6 Months | Baseline and 6 months | Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings. | Baseline and 6 months | Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline |
| Change From Baseline in Total Daily Dose (TDD) | Baseline and 6 months | Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Insulin Pump Therapy Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
Minimed Paradigm 512/712 Insulin pump: Minimed Paradigm 512/712 Insulin pump | 60 |
| Minimed Paradigm Real Time Sytem Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem: Minimed paradigm Real Time Sytem | 55 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 14 |
Baseline characteristics
| Characteristic | Conventional Insulin Pump Therapy | Minimed Paradigm Real Time Sytem | Total |
|---|---|---|---|
| Age, Continuous | 28.8 years STANDARD_DEVIATION 16.7 | 28.1 years STANDARD_DEVIATION 15.1 | 28.5 years STANDARD_DEVIATION 15.9 |
| Region of Enrollment France | 60 participants | 55 participants | 115 participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 55 |
| other Total, other adverse events | 25 / 60 | 16 / 55 |
| serious Total, serious adverse events | 6 / 60 | 2 / 55 |
Outcome results
Primary
Difference in HbA1C From Baseline and 6 Months
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Insulin Pump Therapy | Difference in HbA1C From Baseline and 6 Months | -0.57 percentage of HbA1C | Standard Deviation 0.94 |
| Minimed Paradigm Real Time Sytem | Difference in HbA1C From Baseline and 6 Months | -0.81 percentage of HbA1C | Standard Deviation 1.09 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Insulin Pump Therapy | Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings. | -10.8 mg/dL | Standard Deviation 39.6 |
| Minimed Paradigm Real Time Sytem | Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings. | -30.6 mg/dL | Standard Deviation 54 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Insulin Pump Therapy | Change From Baseline in Total Daily Dose (TDD) | 6.8 units/day | Standard Deviation 17.3 |
| Minimed Paradigm Real Time Sytem | Change From Baseline in Total Daily Dose (TDD) | 1.5 units/day | Standard Deviation 9.1 |