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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)

Conditions
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Stress, Type 1 Diabetes

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetic patients (diagnosed longer than 2 years) HBA1c 5,0 - 9,5 % Age 18-75 years Hospitalized patients Male or female, if female exclusion of pregnancy or secure contraception Body-Mass-Index 19-40 kg/m² Patient is elucidated Patients agreement Exclusion Criteria: Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft HbA1c < 5,0 % or > 9,5 % A severe hypoglycemia with unconsciousness within the last 2 month Body-Mass-Index < 19 or > 40 kg/m² No patient agreement Pregnancy (positive pregnancy test) or unsecured contraception. Agina pectoris or acute myocardial infarct, as continuous problem Inadequate treated arterial hypertension > 160 mmHg systolic and/or < 95 mmHg diastolic Active tumor disease Anemia hemoglobin < 11,5 g/dl Treatment with steroids, sedative or anesthetics Infection/fewer > 37.5 °C Renal- malfunction (serum- creatinine > 1.5 mg/dl) Liver- malfunction (GPT and AP > double of upper- limit) Alcohol or drug abuse Sleep disorder Participation in clinical studies within the last 3 month Other significant health dysfunctions, which would affect the outcome of this study Incapable to conform the requirements of the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Even, low numbers<br>They start with a alarm- clock night. No venous blood drawing. | Other: Continuous glucose monitoring<br>* Glucoday S (microdialysis system). Continuous glucose monitoring all three nights<br>* Other names: Gluco Day S (Menarini Diagnostics);Other: alarm- clock intervention, patient perform blood glucose self monitoring<br>* Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.<br>* Other names: Ordinary alarm clock;Other: nurse intervention<br>* Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .<br>* Other names: professional night nurses;Other: Taking the patients pulse<br>* In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.<br>* Other names: Pulse measurment;Other: Other capillary sample<br>* 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.<br>* Other names: laboratory method (EBIOS, Eppendorf, Hamburg, Germany);|
| Active Comparator: Even, high numbers<br>They start with a nurse performing blood glucose determination. No venous blood drawing. | Other: Continuous glucose monitoring<br>* Glucoday S (microdialysis system). Continuous glucose monitoring all three nights<br>* Other names: Gluco Day S (Menarini Diagnostics);Other: alarm- clock intervention, patient perform blood glucose self monitoring<br>* Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.<br>* Other names: Ordinary alarm clock;Other: nurse intervention<br>* Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .<br>* Other names: professional night nurses;Other: Taking the patients pulse<br>* In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.<br>* Other names: Pulse measurment;Other: Other capillary sample<br>* 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.<br>* Other names: laboratory method (EBIOS, Eppendorf, Hamburg, Germany);|
| Active Comparator: Uneven, low numbers<br>They start with an alarm- clock night and have venous blood drawing. | Other: Continuous glucose monitoring<br>* Glucoday S (microdialysis system). Continuous glucose monitoring all three nights<br>* Other names: Gluco Day S (Menarini Diagnostics);Other: alarm- clock intervention, patient perform blood glucose self monitoring<br>* Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.<br>* Other names: Ordinary alarm clock;Other: nurse intervention<br>* Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .<br>* Other names: professional night nurses;Other: Taking the patients pulse<br>* In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.<br>* Other names: Pulse measurment;Other: Venous blood drawing<br>* 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)<br>* Other names: venous blood drawing from an intravenous catheter;Other: Other capillary sample<br>* 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.<br>* Other names: laboratory method (EBIOS, Eppendorf, Hamburg, Germany);|
| Active Comparator: Uneven, high numbers<br>They start with a nurse performing blood glucose determination and have venous blood drawing. | Other: Continuous glucose monitoring<br>* Glucoday S (microdialysis system). Continuous glucose monitoring all three nights<br>* Other names: Gluco Day S (Menarini Diagnostics);Other: alarm- clock intervention, patient perform blood glucose self monitoring<br>* Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.<br>* Other names: Ordinary alarm clock;Other: nurse intervention<br>* Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .<br>* Other names: professional night nurses;Other: Taking the patients pulse<br>* In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.<br>* Other names: Pulse measurment;Other: Venous blood drawing<br>* 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)<br>* Other names: venous blood drawing from an intravenous catheter;Other: Other capillary sample<br>* 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.<br>* Other names: laboratory method (EBIOS, Eppendorf, Hamburg, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose (continuous glucose monitoring) |  | 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose |  | 22 pm, midnight, 2 am, 4 am, 6:45 am | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal glucose profiles, continuous glucose profiles