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

NCT ID: NCT00467688

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-07-31

Brief Summary

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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

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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

Conditions

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Type 1 Diabetes Hypoglycemia

Keywords

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type 1 diabetes glucose excursion hypoglycemia awareness continuous glucose monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,1

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

Group Type NO_INTERVENTION

Real time access to current glucose values during CGMS

Intervention Type DEVICE

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

A,2

Retrospective analysis of glucose values

Group Type NO_INTERVENTION

Real time access to current glucose values during CGMS

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diagnosis and/or treatment of a current psychiatric disease
* Severe late complications
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forschungsinstitut der Diabetes Akademie Mergentheim

OTHER

Sponsor Role lead

Principal Investigators

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Thomas Haak, MD

Role: PRINCIPAL_INVESTIGATOR

Forschungsinstitut der Diabetes Akademie Mergentheim

Locations

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FIDAM

Bad Mergentheim, , Germany

Site Status

Research Institute of the Diabetes Academy Mergentheim

Bad Mergentheim, , Germany

Site Status

Countries

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Germany

References

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Hermanns N, Kulzer B, Gulde C, Eberle H, Pradler E, Patzelt-Bath A, Haak T. Short-term effects on patient satisfaction of continuous glucose monitoring with the GlucoDay with real-time and retrospective access to glucose values: a crossover study. Diabetes Technol Ther. 2009 May;11(5):275-81. doi: 10.1089/dia.2008.0078.

Reference Type DERIVED
PMID: 19425875 (View on PubMed)

Other Identifiers

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Nr.70-005928713-0

Identifier Type: -

Identifier Source: secondary_id

FIDAM 049-06

Identifier Type: -

Identifier Source: org_study_id