Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00740012
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2008-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-25', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2008-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose (continuous glucose monitoring)', 'timeFrame': '10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights'}], 'secondaryOutcomes': [{'measure': 'Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose', 'timeFrame': '22 pm, midnight, 2 am, 4 am, 6:45 am'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nocturnal glucose profiles', 'continuous glucose profiles'], 'conditions': ['Stress', 'Type 1 Diabetes']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Berndt C, Köthe L, Nawrodt B, Mraz B, Patzelt-Bath A. Glycaemic rises after waking up in response to an alarm clock during the night in type 1 diabetic patients can be avoided by experienced nurses drawing blood in a hospital setting as shown by continuous glucose monitoring (GlucoDayR) (abstract 14). Diabetologia 51 (Suppl. 1): S 12'}, {'pmid': '21246465', 'type': 'DERIVED', 'citation': 'Berndt-Zipfel C, Kothe L, Nawrodt B, Mraz B, Patzelt-Bath A, Nauck MA. Glycaemic rises after waking up in response to an alarm clock in type 1-diabetic patients analysed with continuous glucose monitoring (GlucoDay(R) S). Exp Clin Endocrinol Diabetes. 2011 Jan;119(1):56-8. doi: 10.1055/s-0030-1265162. Epub 2011 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations.\n\nThe purpose of this study was to prove this hypothesis with continuous glucose monitoring over three nights.\n\nNight (a) with an alarm clock set at 2 h intervals for glucose self monitoring,\n\nNight (b) with a nurse performing blood glucose determinations, and\n\nNight (c) with the patients left undisturbed.', 'detailedDescription': '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.\n\nWe want to prove this hypothesis with 30 patients over three nights.\n\nNight (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,\n\nNight (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\n\nNight (c) with the patients left undisturbed.\n\nAll 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.\n\nDuring 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetic patients (diagnosed longer than 2 years)\n* HBA1c 5,0 - 9,5 %\n* Age 18-75 years\n* Hospitalized patients\n* Male or female, if female exclusion of pregnancy or secure contraception\n* Body-Mass-Index 19-40 kg/m²\n* Patient is elucidated\n* Patients agreement\n\nExclusion Criteria:\n\n* Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft\n* HbA1c \\< 5,0 % or \\> 9,5 %\n* A severe hypoglycemia with unconsciousness within the last 2 month\n* Body-Mass-Index \\< 19 or \\> 40 kg/m²\n* No patient agreement\n* Pregnancy (positive pregnancy test) or unsecured contraception.\n* Agina pectoris or acute myocardial infarct, as continuous problem\n* Inadequate treated arterial hypertension \\> 160 mmHg systolic and/or \\< 95 mmHg diastolic\n* Active tumor disease\n* Anemia hemoglobin \\< 11,5 g/dl\n* Treatment with steroids, sedative or anesthetics\n* Infection/fewer \\> 37.5 °C\n* Renal- malfunction (serum- creatinine \\> 1.5 mg/dl)\n* Liver- malfunction (GPT and AP \\> double of upper- limit)\n* Alcohol or drug abuse\n* Sleep disorder\n* Participation in clinical studies within the last 3 month\n* Other significant health dysfunctions, which would affect the outcome of this study\n* Incapable to conform the requirements of the protocol'}, 'identificationModule': {'nctId': 'NCT00740012', 'briefTitle': 'Glycemic Rises After Waking Up In Response To An Alarm Clock In Type 1-Diabetic Patients Analysed With Continuous Glucose Monitoring (GlucoDay®)', 'organization': {'class': 'OTHER', 'fullName': 'Diabeteszentrum Bad Lauterberg im Harz'}, 'officialTitle': 'Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)', 'orgStudyIdInfo': {'id': 'Glucoday BL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Even, low numbers', 'description': 'They start with a alarm- clock night. No venous blood drawing.', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Even, high numbers', 'description': 'They start with a nurse performing blood glucose determination. No venous blood drawing.', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uneven, low numbers', 'description': 'They start with an alarm- clock night and have venous blood drawing.', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uneven, high numbers', 'description': 'They start with a nurse performing blood glucose determination and have venous blood drawing.', 'interventionNames': ['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']}], 'interventions': [{'name': 'Continuous glucose monitoring', 'type': 'OTHER', 'otherNames': ['Gluco Day S (Menarini Diagnostics)'], 'description': 'Glucoday S (microdialysis system). Continuous glucose monitoring all three nights', 'armGroupLabels': ['Even, high numbers', 'Even, low numbers', 'Uneven, high numbers', 'Uneven, low numbers']}, {'name': 'alarm- clock intervention, patient perform blood glucose self monitoring', 'type': 'OTHER', 'otherNames': ['Ordinary alarm clock'], 'description': 'Alarm clock intervention at midnight, 2 a.m., 4 a.m. and 6:45 a.m.', 'armGroupLabels': ['Even, high numbers', 'Even, low numbers', 'Uneven, high numbers', 'Uneven, low numbers']}, {'name': 'nurse intervention', 'type': 'OTHER', 'otherNames': ['professional night nurses'], 'description': 'Nurse intervention: gently drawing capillary sample (blood glucose)at midnight, 2 a.m., 4 a.m. and 6:45 a.m. .', 'armGroupLabels': ['Even, high numbers', 'Even, low numbers', 'Uneven, high numbers', 'Uneven, low numbers']}, {'name': 'Taking the patients pulse', 'type': 'OTHER', 'otherNames': ['Pulse measurment'], 'description': 'In nights (a) and (b) the doctoral candidate takes the patients pulse 5-7 minutes after the alarm clock or the nurse.', 'armGroupLabels': ['Even, high numbers', 'Even, low numbers', 'Uneven, high numbers', 'Uneven, low numbers']}, {'name': 'Venous blood drawing', 'type': 'OTHER', 'otherNames': ['venous blood drawing from an intravenous catheter'], 'description': '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)', 'armGroupLabels': ['Uneven, high numbers', 'Uneven, low numbers']}, {'name': 'Other capillary sample', 'type': 'OTHER', 'otherNames': ['laboratory method (EBIOS, Eppendorf, Hamburg, Germany)'], 'description': '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.', 'armGroupLabels': ['Even, high numbers', 'Even, low numbers', 'Uneven, high numbers', 'Uneven, low numbers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37431', 'city': 'Bad Lauterberg im Harz', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Diabeteszentrum Bad Lauterberg im Harz', 'geoPoint': {'lat': 51.63272, 'lon': 10.47031}}], 'overallOfficials': [{'name': 'Michael A. Nauck, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabeteszentrum Bad Lauterberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diabeteszentrum Bad Lauterberg im Harz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Berlin-Chemie Menarini', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Michael Nauck', 'oldOrganization': 'Diabeteszentrum Bad Lauterberg'}}}}