Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

• NCT number: NCT00467688
• Study type: Interventional
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Completion date: July 2007