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

Forschungsinstitut der Diabetes Akademie Mergentheim

Status: Completed

Conditions: Hypoglycemia; Type 1 Diabetes

Treatments: Device: Real time access to current glucose values during CGMS

Study type: Interventional

Funder types: Other

Identifiers

NCT00467688

Nr.70-005928713-0

FIDAM 049-06

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A,1

No Intervention group

Description:

Real time access to current measured glucose values; hyperglycemic or hypoglycemic alerts

Treatment:

Device: Real time access to current glucose values during CGMS

A,2

No Intervention group

Description:

Retrospective analysis of glucose values

Treatment:

Device: Real time access to current glucose values during CGMS