Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
Condition: Stress; Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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).
    

Intervention name(s): Continuous glucose monitoring; alarm- clock intervention, patient perform blood glucose self monitoring; nurse intervention; Taking the patients pulse; Venous blood drawing; Other capillary sample
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Glucoday S (microdialysis system). Continuous glucose monitoring all three nights; Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.; Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .; In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.; 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); 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 intervention name(s): Gluco Day S (Menarini Diagnostics); Ordinary alarm clock; professional night nurses; Pulse measurment; venous blood drawing from an intravenous catheter; laboratory method (EBIOS, Eppendorf, Hamburg, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Nocturnal glucose profiles; continuous glucose profiles