Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes
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
2 other identifiers
interventional
50
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 31, 2007
October 1, 2007
April 30, 2007
October 30, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
A,1
NO INTERVENTIONReal time access to current measured glucose values; hyperglycemic or hypoglycemic alerts
A,2
NO INTERVENTIONRetrospective analysis of glucose values
Interventions
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
Eligibility Criteria
You may qualify if:
- type 1 diabetes
- Age \> 18 years
- Informed consent
You may not qualify if:
- Diagnosis and/or treatment of a current psychiatric disease
- Severe late complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
FIDAM
Bad Mergentheim, D-97980, Germany
Research Institute of the Diabetes Academy Mergentheim
Bad Mergentheim, D-97980, Germany
Related Publications (1)
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.
PMID: 19425875DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Haak, MD
Forschungsinstitut der Diabetes Akademie Mergentheim
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2007
First Posted
May 1, 2007
Study Start
February 1, 2007
Study Completion
July 1, 2007
Last Updated
October 31, 2007
Record last verified: 2007-10