Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111228
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2005-05-18
Brief Title:
The Guardcontrol Trial Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lowhigh 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 81 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
The Guardian RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and lowhigh 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 81 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None