Effectiveness Study of the Guardian RT in Type 1 Diabetics
This study has been completed.
Sponsor:
Medtronic Diabetes
Information provided by:
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01331343
First received: April 5, 2011
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Device: Guardian RT Telemetered Glucose Monitoring System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by Medtronic Diabetes:
Primary Outcome Measures:
- Difference in Change in A1c (%) between continuous use of CGM and control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Difference in change in A1c (%) between biweekly use of CGM and control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 156 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
Eligibility| Ages Eligible for Study: | 8 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 Diabetes for at least 12 months
- HbA1c must be 8.1% or above at study entry
- Intensive Insulin Therapy 3 months prior to study entry
Exclusion Criteria:
- Impaired hearing or vision (must see screens and hear alarms)
- Unable to comply with protocol
- Chronic debilitating or psychiatric disturbances
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331343
Locations
| France | |
| Hospital Sud Francilien | |
| Corbeil-Essonnes Cedex, France | |
| CH Robert Debre | |
| Paris, France | |
| Germany | |
| Klinik fur Allgemeine Charite | |
| Berlin, Germany | |
| Israel | |
| Schneider Children Centre | |
| Petah Tikva, Israel | |
| Italy | |
| U.O. Medicina Generale | |
| Milano, Italy | |
| Slovenia | |
| University Children's Hospital | |
| Ljubljana, Slovenia | |
| Sweden | |
| Huddinge University Hospital | |
| Huddinge, Sweden | |
| United Kingdom | |
| Royal Bournemouth Hospital | |
| Dorset, United Kingdom | |
Sponsors and Collaborators
Medtronic Diabetes
More Information
No publications provided
| Responsible Party: | Severine Liabat, Medtronic Internationtal Trading Sarl |
| ClinicalTrials.gov Identifier: | NCT01331343 History of Changes |
| Other Study ID Numbers: | EU007_022004 |
| Study First Received: | April 5, 2011 |
| Last Updated: | April 15, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Medtronic Diabetes:
|
Diabetes Glycemic Control Continuous Glucose Monitoring |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013