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

This study has been completed.
Sponsor:
Information provided by:
Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT00467688
First received: April 30, 2007
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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


Condition Intervention
Type 1 Diabetes
Hypoglycemia
Device: Real time access to current glucose values during CGMS

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

Resource links provided by NLM:


Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time spent in euglycemic and hyperglycemic glucose range Satisfaction with CGMS Diabetes related distress Treatment satisfaction Anxiety and depressive symptoms [ Time Frame: During and after the 48 hours measurement of CGMS ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: July 2007
Arms Assigned Interventions
No Intervention: A,1
Real time access to current measured glucose values; hyperglycemic or hypoglycemic alerts
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
No Intervention: A,2
Retrospective analysis of glucose values
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467688

Locations
Germany
Research Institute of the Diabetes Academy Mergentheim
Bad Mergentheim, Germany, D-97980
FIDAM
Bad Mergentheim, Germany, D-97980
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
Principal Investigator: Thomas Haak, MD Forschungsinstitut der Diabetes Akademie Mergentheim
  More Information

No publications provided by Forschungsinstitut der Diabetes Akademie Mergentheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00467688     History of Changes
Other Study ID Numbers: FIDAM 049-06, Nr.70-005928713-0
Study First Received: April 30, 2007
Last Updated: October 30, 2007
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
type 1 diabetes
glucose excursion
hypoglycemia awareness
continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014