Type 1 Diabetes Clinical Trial
Official title:
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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