Status:
COMPLETED
Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
Lead Sponsor:
Diabeteszentrum Bad Lauterberg im Harz
Collaborating Sponsors:
Berlin-Chemie Menarini
Conditions:
Stress
Type 1 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations. The purpose of this study was to prove this hypothesis with continuo...
Detailed Description
To provide nocturnal glucose control in patients with type 1 diabetes is a therapeutic challenge. Nocturnal glucose profiles are an important tool to secure adequate glycemic control during the night....
Eligibility Criteria
Inclusion
- Type 1 Diabetic patients (diagnosed longer than 2 years)
- HBA1c 5,0 - 9,5 %
- Age 18-75 years
- Hospitalized patients
- Male or female, if female exclusion of pregnancy or secure contraception
- Body-Mass-Index 19-40 kg/m²
- Patient is elucidated
- Patients agreement
Exclusion
- Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft
- HbA1c \< 5,0 % or \> 9,5 %
- A severe hypoglycemia with unconsciousness within the last 2 month
- Body-Mass-Index \< 19 or \> 40 kg/m²
- No patient agreement
- Pregnancy (positive pregnancy test) or unsecured contraception.
- Agina pectoris or acute myocardial infarct, as continuous problem
- Inadequate treated arterial hypertension \> 160 mmHg systolic and/or \< 95 mmHg diastolic
- Active tumor disease
- Anemia hemoglobin \< 11,5 g/dl
- Treatment with steroids, sedative or anesthetics
- Infection/fewer \> 37.5 °C
- Renal- malfunction (serum- creatinine \> 1.5 mg/dl)
- Liver- malfunction (GPT and AP \> double of upper- limit)
- Alcohol or drug abuse
- Sleep disorder
- Participation in clinical studies within the last 3 month
- Other significant health dysfunctions, which would affect the outcome of this study
- Incapable to conform the requirements of the protocol
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00740012
Start Date
March 1 2007
End Date
September 1 2008
Last Update
September 29 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabeteszentrum Bad Lauterberg im Harz
Bad Lauterberg im Harz, Lower Saxony, Germany, 37431