An interventional study of Continuous glucose monitoring and alarm- clock intervention, patient perform blood glucose self monitoring in Stress and Type 1 Diabetes, sponsored by Diabeteszentrum Bad Lauterberg im Harz. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-09-29.
Sponsored by Diabeteszentrum Bad Lauterberg im Harz · Not applicable and Interventional
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).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Diabeteszentrum Bad Lauterberg im Harz is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
They start with a alarm- clock night. No venous blood drawing.
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
They start with a nurse performing blood glucose determination. No venous blood drawing.
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
They start with an alarm- clock night and have venous blood drawing.
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
They start with a nurse performing blood glucose determination and have venous blood drawing.
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
Glucoday S (microdialysis system). Continuous glucose monitoring all three nights
Also known as: Gluco Day S (Menarini Diagnostics)
Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.
Also known as: Ordinary alarm clock
Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .
Also known as: professional night nurses
In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.
Also known as: Pulse measurment
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)
Also known as: venous blood drawing from an intravenous catheter
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.
Also known as: laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
Glucose (continuous glucose monitoring)
Time frame: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights
Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose
Time frame: 22 pm, midnight, 2 am, 4 am, 6:45 am
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Diabeteszentrum Bad Lauterberg im Harz