Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)

This study has been completed.
Sponsor:
Collaborator:
Berlin-Chemie Menarini
Information provided by:
Diabeteszentrum Bad Lauterberg im Harz
ClinicalTrials.gov Identifier:
NCT00740012
First received: August 20, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Stress
Type 1 Diabetes
Other: Continuous glucose monitoring
Other: alarm- clock intervention, patient perform blood glucose self monitoring
Other: nurse intervention
Other: Taking the patients pulse
Other: Venous blood drawing
Other: Other capillary sample

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)

Resource links provided by NLM:


Further study details as provided by Diabeteszentrum Bad Lauterberg im Harz:

Primary Outcome Measures:
  • Glucose (continuous glucose monitoring) [ Time Frame: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose [ Time Frame: 22 pm, midnight, 2 am, 4 am, 6:45 am ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Even, low numbers
They start with a alarm- clock night. No venous blood drawing.
Other: Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Other Name: Gluco Day S (Menarini Diagnostics)
Other: 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.
Other Name: Ordinary alarm clock
Other: nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Other Name: professional night nurses
Other: 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 Name: Pulse measurment
Other: 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 Name: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
Active Comparator: Even, high numbers
They start with a nurse performing blood glucose determination. No venous blood drawing.
Other: Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Other Name: Gluco Day S (Menarini Diagnostics)
Other: 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.
Other Name: Ordinary alarm clock
Other: nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Other Name: professional night nurses
Other: 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 Name: Pulse measurment
Other: 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 Name: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
Active Comparator: Uneven, low numbers
They start with an alarm- clock night and have venous blood drawing.
Other: Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Other Name: Gluco Day S (Menarini Diagnostics)
Other: 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.
Other Name: Ordinary alarm clock
Other: nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Other Name: professional night nurses
Other: 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 Name: Pulse measurment
Other: 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 Name: venous blood drawing from an intravenous catheter
Other: 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 Name: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
Active Comparator: Uneven, high numbers
They start with a nurse performing blood glucose determination and have venous blood drawing.
Other: Continuous glucose monitoring
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Other Name: Gluco Day S (Menarini Diagnostics)
Other: 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.
Other Name: Ordinary alarm clock
Other: nurse intervention
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Other Name: professional night nurses
Other: 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 Name: Pulse measurment
Other: 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 Name: venous blood drawing from an intravenous catheter
Other: 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 Name: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)

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. Often, patients are asked to perform self-monitoring with the help of an alarm clock. Such a recommendation depends on the accuracy of glucose concentrations determined this way. We hypothesized that alarm clocks may trigger a stressful arousal that might be accompanied by rises in glucose concentrations, consecutively leading to nocturnal glucose profiles that are not representative for undisturbed conditions.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00740012

Locations
Germany
Diabeteszentrum Bad Lauterberg im Harz
Bad Lauterberg, Lower Saxony, Germany, 37431
Sponsors and Collaborators
Diabeteszentrum Bad Lauterberg im Harz
Berlin-Chemie Menarini
Investigators
Principal Investigator: Michael A. Nauck, professor Diabeteszentrum Bad Lauterberg
  More Information

Publications:
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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Michael Nauck, Diabeteszentrum Bad Lauterberg
ClinicalTrials.gov Identifier: NCT00740012     History of Changes
Other Study ID Numbers: Glucoday BL
Study First Received: August 20, 2008
Last Updated: September 25, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Diabeteszentrum Bad Lauterberg im Harz:
Nocturnal glucose profiles
continuous glucose profiles

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014