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Clinical Trials/NCT00467688
NCT00467688
Completed
Not Applicable

The Effect of Continuous Glucose Monitoring With and Without Real Time Access to Glucose Values and Glucose Alerts on Course of Glucose and Satisfaction With CGMS in Type 1 Diabetic Patients

Forschungsinstitut der Diabetes Akademie Mergentheim2 sites in 1 country50 target enrollmentFebruary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim
Enrollment
50
Locations
2
Primary Endpoint
Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access satisfaction with CGMS during both conditions

Detailed Description

The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges. The second objective is to access satisfaction with CGMS during both conditions. This study is conducted in an inpatient setting with type 1 diabetic patients. Partisans are asked to have twice a continuous glucose measurement with the GlucoDay System (Menarini Diagnostics). Each measurement period is limited to maximal 48 hours. In one condition the have real time access to current glucose values and alerts are given if glucose is dropping below 70 mg/dl or exceeding 180 mg/dl. During the other condition the participants are blind against their current glucose values and no alerts are given. Glucose course is retrospectively analyzed. The order of these two conditions is randomized. Expected outcome: The primary outcome variable is the daily time spent in hypoglycemic range in type 1 diabetic patients with and without impaired hypoglycemia awareness or a history of severe hypoglycemia. Additionally the patients will also complete questionnaire about satisfaction with CGMS, diabetes related distress, treatment satisfaction, depressive and anxiety symptoms which belongs to the secondary variables. Inclusion criteria: * Type 1 diabetes * Age \> 18 years * Informed consent Exclusion criteria: * Diagnosis and/or treatment of a current psychiatric disease * Severe late complications

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
July 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim

Eligibility Criteria

Inclusion Criteria

  • type 1 diabetes
  • Age \> 18 years
  • Informed consent

Exclusion Criteria

  • Diagnosis and/or treatment of a current psychiatric disease
  • Severe late complications

Outcomes

Primary Outcomes

Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms

Time Frame: during the 48 hours of using blind vs. unblind continuous glucose monitoring

Secondary Outcomes

  • Time spent in euglycemic and hyperglycemic glucose range Satisfaction with CGMS Diabetes related distress Treatment satisfaction Anxiety and depressive symptoms(During and after the 48 hours measurement of CGMS)

Study Sites (2)

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