Diabetes Mellitus
Conditions
Keywords
Diabetes
Brief summary
The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.
Detailed description
Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic extremes. Nevertheless, there are still patients who fail to achieve good control due to fear of hypoglycemia, or who underestimate post-prandial hyperglycemias. The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data. The overall primary objective of the study is to determine whether patients with poor glycemic control as evidenced by HbA1c \> 8.1% can achieve improved metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks (control group) after 12 weeks of continuous use.
Interventions
DEVICEGuardian RT
DEVICESMBG only
SMBG only
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient has signed Informed consent form prior to Study Entry. * Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry. * HbA1c must be 8.1% or above at study entry day (central lab value). * Patients must perform at least two self-monitoring blood glucose finger-sticks daily. * Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily. * Patients on intensive insulin therapy must be on continuous subcutaneous insulin infusion (CSII) or MDI at least 3 months prior to inclusion and should have been receiving diabetes care from the investigator of each centre for the 6 months prior to inclusion. * Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses. * Patients are willing to undergo all study procedures. * Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia. * Patients are willing to participate in a Guardian® RT product training course * Patients understand how to adjust and administer corrective treatment.
Exclusion criteria
* Patient has hearing problems/is deaf. * Patient has impaired vision/blindness so screen alarms cannot be recognized. * Alcohol or drug abuse other than nicotine. * Allergy to sensor or components of the sensor. * Manifest psychiatric disturbances. * Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions. * Patient does not have a reliable support person. * Patient is unwilling or unable to comply with the provisions of the protocol. * Patient has scheduled travel on a plane in the next 3 months. * Patient has scheduled a vacation which will occur between Visit 1 and Visit 2. * Patient is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this study once. Patient has already participated in the Centre Qualification Phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period | baseline and 3 month after study | Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline | baseline and 3 month after study | Average blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline |
Countries
France, Germany, Israel, Italy, Slovenia, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Use of the Guardian RT Continuous use of the Guardian RT group
Guardian RT | 54 |
| Bi-weekly Use of the Guardian RT (Once Every 2 Weeks) Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT | 54 |
| Control Group. SMBG Monitoring Control group. SMBG monitoring group
SMBG only: SMBG only | 54 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Continuous Use of the Guardian RT | Bi-weekly Use of the Guardian RT (Once Every 2 Weeks) | Control Group. SMBG Monitoring | Total |
|---|---|---|---|---|
| Age, Continuous | 26.24 Years STANDARD_DEVIATION 13.39 | 25.92 Years STANDARD_DEVIATION 14.03 | 27.42 Years STANDARD_DEVIATION 16.53 | 26.52 Years STANDARD_DEVIATION 14.63 |
| Sex: Female, Male Female | 29 Participants | 16 Participants | 26 Participants | 71 Participants |
| Sex: Female, Male Male | 25 Participants | 38 Participants | 28 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 15 / 54 | 15 / 54 | 10 / 54 |
| serious Total, serious adverse events | 2 / 54 | 2 / 54 | 2 / 54 |
Outcome results
Primary
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
Time frame: baseline and 3 month after study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Use of the Guardian RT | Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period | -0.99 percentage of HbA1C | Standard Deviation 1.13 |
| Bi-weekly Use of the Guardian RT (Once Every 2 Weeks) | Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period | -0.70 percentage of HbA1C | Standard Deviation 1.27 |
| Control Group. SMBG Monitoring | Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period | -0.39 percentage of HbA1C | Standard Deviation 1.03 |
Secondary
Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline
Average blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline
Time frame: baseline and 3 month after study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Use of the Guardian RT | Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline | -12.38 mg/dL | Standard Deviation 44.18 |
| Bi-weekly Use of the Guardian RT (Once Every 2 Weeks) | Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline | -12.17 mg/dL | Standard Deviation 50.37 |
| Control Group. SMBG Monitoring | Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline | -2.21 mg/dL | Standard Deviation 45.1 |