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

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ClinicalTrials.gov Identifier: NCT00467688
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : October 31, 2007
Sponsor:
Information provided by:
Forschungsinstitut der Diabetes Akademie Mergentheim

Tracking Information
First Submitted Date  ICMJE April 30, 2007
First Posted Date  ICMJE May 1, 2007
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE February 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00467688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes
Official Title  ICMJE 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
Brief 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes
  • Hypoglycemia
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: A,1
    Real time access to current measured glucose values; hyperglycemic or hypoglycemic alerts
    Intervention: Device: Real time access to current glucose values during CGMS
  • No Intervention: A,2
    Retrospective analysis of glucose values
    Intervention: Device: Real time access to current glucose values during CGMS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2007)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosis and/or treatment of a current psychiatric disease
  • Severe late complications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467688
Other Study ID Numbers  ICMJE FIDAM 049-06
Nr.70-005928713-0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Forschungsinstitut der Diabetes Akademie Mergentheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Haak, MD Forschungsinstitut der Diabetes Akademie Mergentheim
PRS Account Forschungsinstitut der Diabetes Akademie Mergentheim
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP