NCT00740012

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®)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Diabeteszentrum Bad Lauterberg im Harz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Stress
• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-22
• Last updated: 2008-09-29

Locations

1 site across 1 country: Germany