An interventional study of Real time access to current glucose values during CGMS in Type 1 Diabetes and Hypoglycemia, sponsored by Forschungsinstitut der Diabetes Akademie Mergentheim. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-31.
Sponsored by Forschungsinstitut der Diabetes Akademie Mergentheim · Not applicable, Interventional, and Treatment
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
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:
Exclusion criteria:
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Forschungsinstitut der Diabetes Akademie Mergentheim is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Real time access to current measured glucose values; hyperglycemic or hypoglycemic alerts
Device: Real time access to current glucose values during CGMS
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
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
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
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Forschungsinstitut der Diabetes Akademie Mergentheim