Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
NCT ID: NCT00740012
Last Updated: 2008-09-29
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2007-03-31
2008-09-30
Brief Summary
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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.
Detailed Description
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We want to prove this hypothesis with 30 patients over three nights.
Night (a) with an alarm clock set at 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m) for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations at the 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m), and
Night (c) with the patients left undisturbed.
All the patients are going to use a continuous glucose monitor and half of the patients (uneven numbers) are going to have an indwelling venous cannula during night (a) and (b.
During night (a) and (b) 5-7 minutes after the scheduled times for glucose measurements the doctoral candidate is going to take the pulse, another capillary blood sample for a laboratory glucose determination (EBIOS, Eppendorf, Hamburg, Germany). Also the doctoral candidate is going to take a venous blood sample in half of the patients (uneven numbers), blood from the indwelling venous cannula for the determination of epinephrine, norepinephrine, cortisol, glucagon, growth hormone, and prolactin (determined by specific immunoassays at Biocientia laboratories, Jena, Germany).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Even, low numbers
They start with a alarm- clock night. No venous blood drawing.
Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoring
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulse
In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
Other capillary sample
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.
Even, high numbers
They start with a nurse performing blood glucose determination. No venous blood drawing.
Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoring
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulse
In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
Other capillary sample
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.
Uneven, low numbers
They start with an alarm- clock night and have venous blood drawing.
Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoring
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulse
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
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)
Other capillary sample
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.
Uneven, high numbers
They start with a nurse performing blood glucose determination and have venous blood drawing.
Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoring
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulse
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
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)
Other capillary sample
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.
Interventions
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Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
alarm- clock intervention, patient perform blood glucose self monitoring
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Taking the patients pulse
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
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)
Other capillary sample
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Berlin-Chemie Menarini
INDUSTRY
Diabeteszentrum Bad Lauterberg im Harz
OTHER
Responsible Party
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Diabeteszentrum Bad Lauterberg
Principal Investigators
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Michael A. Nauck, professor
Role: PRINCIPAL_INVESTIGATOR
Diabeteszentrum Bad Lauterberg
Locations
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Diabeteszentrum Bad Lauterberg im Harz
Bad Lauterberg im Harz, Lower Saxony, Germany
Countries
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References
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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
Berndt-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.
Other Identifiers
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Glucoday BL
Identifier Type: -
Identifier Source: org_study_id