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

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.

Conditions

• Stress
• Type 1 Diabetes

Interventions

OTHER

Continuous glucose monitoring

Glucoday S (microdialysis system). Continuous glucose monitoring all three nights

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

nurse intervention

Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .

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

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

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.

Sponsors & Collaborators

• Berlin-Chemie Menarini

  collaborator INDUSTRY

• Diabeteszentrum Bad Lauterberg im Harz

  lead OTHER

Principal Investigators

• Michael A. Nauck, professor · Diabeteszentrum Bad Lauterberg

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• Germany

Study Locations