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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467688
• Other study ID #: FIDAM 049-06
• Secondary ID: Nr.70-005928713-
• Status: Completed
• Phase: N/A
• First received: April 30, 2007
• Last updated: October 30, 2007
• Start date: February 2007
• Est. completion date: July 2007

Study information

• Verified date: October 2007
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention

Device:
• Real time access to current glucose values during CGMS
One arm gets real time access to current measured glucose values and hypoglycemic or hyperglycemic alerts are elicited, The second arm get´s a retrospective analysis of glucose values

Locations

Country	Name	City	State
Germany	FIDAM	Bad Mergentheim
Germany	Research Institute of the Diabetes Academy Mergentheim	Bad Mergentheim

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms		during the 48 hours of using blind vs. unblind continuous glucose monitoring
Secondary	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