Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)
1 other identifier
interventional
32
1 country
1
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 continuous glucose monitoring over three nights. Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring, Night (b) with a nurse performing blood glucose determinations, and Night (c) with the patients left undisturbed.
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 Mar 2007
1 active site
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
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 29, 2008
September 1, 2008
1.5 years
August 20, 2008
September 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose (continuous glucose monitoring)
10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights
Secondary Outcomes (1)
Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose
22 pm, midnight, 2 am, 4 am, 6:45 am
Study Arms (4)
Even, low numbers
ACTIVE COMPARATORThey start with a alarm- clock night. No venous blood drawing.
Even, high numbers
ACTIVE COMPARATORThey start with a nurse performing blood glucose determination. No venous blood drawing.
Uneven, low numbers
ACTIVE COMPARATORThey start with an alarm- clock night and have venous blood drawing.
Uneven, high numbers
ACTIVE COMPARATORThey start with a nurse performing blood glucose determination and have venous blood drawing.
Interventions
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
Venous blood drawing for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany) (6-10 minutes after midnight, 2 a.m., 4 a.m. and 6:45 a.m.)in night (a) and (b)
5-7 minutes after the alarm clock or the nurse the doctoral candidate takes another capillary sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany) analyzer.
Eligibility Criteria
You may qualify if:
- Type 1 Diabetic patients (diagnosed longer than 2 years)
- HBA1c 5,0 - 9,5 %
- Age 18-75 years
- Hospitalized patients
- Body-Mass-Index 19-40 kg/m²
- Patient is elucidated
- Patients agreement
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diabeteszentrum Bad Lauterberg im Harzlead
- Berlin-Chemie Menarinicollaborator
Study Sites (1)
Diabeteszentrum Bad Lauterberg im Harz
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
Related Publications (2)
Berndt C, Köthe L, Nawrodt B, Mraz B, Patzelt-Bath A. Glycaemic rises after waking up in response to an alarm clock during the night in type 1 diabetic patients can be avoided by experienced nurses drawing blood in a hospital setting as shown by continuous glucose monitoring (GlucoDayR) (abstract 14). Diabetologia 51 (Suppl. 1): S 12
RESULTBerndt-Zipfel C, Kothe L, Nawrodt B, Mraz B, Patzelt-Bath A, Nauck MA. Glycaemic rises after waking up in response to an alarm clock in type 1-diabetic patients analysed with continuous glucose monitoring (GlucoDay(R) S). Exp Clin Endocrinol Diabetes. 2011 Jan;119(1):56-8. doi: 10.1055/s-0030-1265162. Epub 2011 Jan 18.
PMID: 21246465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Nauck, professor
Diabeteszentrum Bad Lauterberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 22, 2008
Study Start
March 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
September 29, 2008
Record last verified: 2008-09