Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467688
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2007-04-30
Brief Title:
Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes
Sponsor:
Forschungsinstitut der Diabetes Akademie Mergentheim
Organization:
Forschungsinstitut der Diabetes Akademie Mergentheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgdl or exceeding 180 mgdl 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 andor treatment of a current psychiatric disease
Severe late complications
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 mgdl or exceeding 180 mgdl 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 andor treatment of a current psychiatric disease
Severe late complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Nr70-005928713-0 | None | None | None |