Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 12:15 AM
Study NCT ID:
NCT01696266
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2012-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29304}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of any hypoglycaemic event', 'timeFrame': 'In the 4 weeks prior to and following the baseline visit (Week 0)'}], 'secondaryOutcomes': [{'measure': 'Difference in the reported incidence rates of any hypoglycaemia', 'timeFrame': 'In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit'}, {'measure': 'Incidence of hypoglycaemic events requiring hospital admission', 'timeFrame': 'In the 6 months prior to and 4 weeks following the baseline visit'}, {'measure': 'Incidence of all severe hypoglycaemic events', 'timeFrame': 'In the 6 months prior to and 4 weeks following the baseline visit'}, {'measure': 'Incidence of probable symptomatic hypoglycaemic events', 'timeFrame': 'In the 4 weeks prior to and following the baseline visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '27161418', 'type': 'RESULT', 'citation': 'Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters-Weijnen C, Forsen T, Galstyan G, Geelhoed-Duijvestijn P, Goldfracht M, Gydesen H, Kapur R, Lalic N, Ludvik B, Moberg E, Pedersen-Bjergaard U, Ramachandran A; HAT Investigator Group. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016 Sep;18(9):907-15. doi: 10.1111/dom.12689. Epub 2016 Jun 20.'}, {'pmid': '28602812', 'type': 'RESULT', 'citation': 'Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters-Weijnen C, Forsen T, Galstyan G, Geelhoed-Duijvestijn P, Goldfracht M, Gydesen H, Kapur R, Lalic N, Ludvik B, Moberg E, Pedersen-Bjergaard U, Ramachandran A; HAT Investigator Group. Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes. Diabetes Res Clin Pract. 2017 Aug;130:121-129. doi: 10.1016/j.diabres.2017.05.004. Epub 2017 May 12.'}, {'pmid': '28750429', 'type': 'RESULT', 'citation': 'Kern W, Holstein A, Moenninghoff C, Kienhofer J, Riedl M, Kulzer B. Self-reported Hypoglycaemic Events in 2 430 Patients with Insulin-treated Diabetes in the German Sub-population of the HAT Study. Exp Clin Endocrinol Diabetes. 2017 Oct;125(9):592-597. doi: 10.1055/s-0043-112350. Epub 2017 Jul 27.'}, {'pmid': '29062399', 'type': 'RESULT', 'citation': 'Pongrac Barlovic D, Zavratnik A, Skvarca A, Jansa K, Vukelic B, Tomazic M, Ravnik Oblak M. Self-reported Hypoglycaemia in Patients treated with Insulin: A Large Slovenian Retrospectively-prospective Study. Zdr Varst. 2017 Oct 9;56(4):244-250. doi: 10.1515/sjph-2017-0033. eCollection 2017 Oct.'}, {'pmid': '28528246', 'type': 'RESULT', 'citation': 'Aronson R, Goldenberg R, Boras D, Skovgaard R, Bajaj H. The Canadian Hypoglycemia Assessment Tool Program: Insights Into Rates and Implications of Hypoglycemia From an Observational Study. Can J Diabetes. 2018 Feb;42(1):11-17. doi: 10.1016/j.jcjd.2017.01.007. Epub 2017 May 17.'}, {'pmid': '28888148', 'type': 'RESULT', 'citation': 'Hussein Z, Kamaruddin NA, Chan SP, Jain A, Uppal S, Bebakar WMW; HAT study investigators in Malaysia. Hypoglycemia awareness among insulin-treated patients with diabetes in Malaysia: A cohort subanalysis of the HAT study. Diabetes Res Clin Pract. 2017 Nov;133:40-49. doi: 10.1016/j.diabres.2017.08.007. Epub 2017 Aug 14.'}, {'pmid': '29355651', 'type': 'RESULT', 'citation': 'Aronson R, Galstyan G, Goldfracht M, Al Sifri S, Elliott L, Khunti K. Direct and indirect health economic impact of hypoglycaemia in a global population of patients with insulin-treated diabetes. Diabetes Res Clin Pract. 2018 Apr;138:35-43. doi: 10.1016/j.diabres.2018.01.007. Epub 2018 Jan 31.'}, {'pmid': '29524189', 'type': 'RESULT', 'citation': 'Haluzik M, Kretowski A, Strojek K, Czupryniak L, Janez A, Kempler P, Andel M, Tankova T, Boyanov M, Smircic Duvnjak L, Madacsy L, Tarnowska I, Zychma M, Lalic N. Perspectives of Patients with Insulin-Treated Type 1 and Type 2 Diabetes on Hypoglycemia: Results of the HAT Observational Study in Central and Eastern European Countries. Diabetes Ther. 2018 Apr;9(2):727-741. doi: 10.1007/s13300-018-0388-2. Epub 2018 Mar 9.'}, {'pmid': '29581204', 'type': 'RESULT', 'citation': 'de Groot S, Enters-Weijnen CF, Geelhoed-Duijvestijn PH, Kanters TA. A cost of illness study of hypoglycaemic events in insulin-treated diabetes in the Netherlands. BMJ Open. 2018 Mar 25;8(3):e019864. doi: 10.1136/bmjopen-2017-019864.'}, {'pmid': '29729048', 'type': 'RESULT', 'citation': 'Khunti K, Cigrovski Berkovic M, Ludvik B, Moberg E, Barner Lekdorf J, Gydesen H, Pedersen-Bjergaard U. Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin-treated Type 2 diabetes mellitus. Diabet Med. 2018 May 5;35(9):1232-41. doi: 10.1111/dme.13662. Online ahead of print.'}, {'pmid': '30456887', 'type': 'RESULT', 'citation': 'Pedersen-Bjergaard U, Alsifri S, Aronson R, Berkovic MC, Galstyan G, Gydesen H, Lekdorf JB, Ludvik B, Moberg E, Ramachandran A, Khunti K. Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies. Diabetes Obes Metab. 2019 Apr;21(4):844-853. doi: 10.1111/dom.13588. Epub 2018 Dec 17.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Insulin-treated patients with Type 1 or Type 2 diabetes mellitus. Patients should be ambulatory, literate, have used insulin for at least 12 months, and be over 18 years of age to be able to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months\n* Patients giving informed consent to participate in the survey\n\nExclusion Criteria:\n\n* Non-ambulatory patients\n* Illiterate patients and patients otherwise unable to complete a written survey'}, 'identificationModule': {'nctId': 'NCT01696266', 'briefTitle': 'An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes', 'orgStudyIdInfo': {'id': 'INS-4019'}, 'secondaryIdInfos': [{'id': 'U1111-1132-1910', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin-treated patients with diabetes', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).', 'armGroupLabels': ['Insulin-treated patients with diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1636DSU', 'city': 'Prov. de Buenos Aires', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'A-1010', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'L4W 4XI', 'city': 'Mississauga', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '16000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2300', 'city': 'Copenhagen S', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'FI-02600', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '55127', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '1025', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '560001', 'city': 'Bangalore', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '44425', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '11844', 'city': 'Amman', 'country': 'Lebanon', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Selangor Darul Ehsan', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Alphen aan den Rijn', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.12917, 'lon': 4.65546}}, {'zip': 'PL-02-274', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '010031', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '119330', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '3542', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '11070', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '811 05', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': 'SI-1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '202 15', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}