Randomised, Controlled, Multi-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of Guardian T Versus Conventional Self-Monitoring Blood Glucose
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Medtronic Diabetes
- Enrollment
- 162
- Locations
- 8
- Primary Endpoint
- Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
Time Frame: 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 Outcomes
- 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)