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

August 20, 2008
September 25, 2008
March 2007
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00740012 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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®)

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Stress
  • Type 1 Diabetes
  • 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: Even, low numbers
    They start with a alarm- clock night. No venous blood drawing.
    Interventions:
    • Other: Continuous glucose monitoring
    • Other: alarm- clock intervention, patient perform blood glucose self monitoring
    • Other: nurse intervention
    • Other: Taking the patients pulse
    • Other: Other capillary sample
  • Active Comparator: Even, high numbers
    They start with a nurse performing blood glucose determination. No venous blood drawing.
    Interventions:
    • Other: Continuous glucose monitoring
    • Other: alarm- clock intervention, patient perform blood glucose self monitoring
    • Other: nurse intervention
    • Other: Taking the patients pulse
    • Other: Other capillary sample
  • Active Comparator: Uneven, low numbers
    They start with an alarm- clock night and have venous blood drawing.
    Interventions:
    • 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
  • Active Comparator: Uneven, high numbers
    They start with a nurse performing blood glucose determination and have venous blood drawing.
    Interventions:
    • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00740012
Glucoday BL
No
Prof. Dr. Michael Nauck, Diabeteszentrum Bad Lauterberg
Diabeteszentrum Bad Lauterberg im Harz
Berlin-Chemie Menarini
Principal Investigator: Michael A. Nauck, professor Diabeteszentrum Bad Lauterberg
Diabeteszentrum Bad Lauterberg im Harz
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP