An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
NCT ID: NCT01696266
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29304 participants
OBSERVATIONAL
2012-09-05
2013-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Insulin-treated patients with diabetes
No treatment given
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).
Interventions
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No treatment given
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).
Eligibility Criteria
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Inclusion Criteria
* Patients giving informed consent to participate in the survey
Exclusion Criteria
* Illiterate patients and patients otherwise unable to complete a written survey
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Prov. de Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Mississauga, , Canada
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Copenhagen S, , Denmark
Novo Nordisk Investigational Site
Espoo, , Finland
Novo Nordisk Investigational Site
Mainz, , Germany
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Bangalore, , India
Novo Nordisk Investigational Site
Kfar Saba, , Israel
Novo Nordisk Investigational Site
Amman, , Lebanon
Novo Nordisk Investigational Site
Selangor Darul Ehsan, , Malaysia
Novo Nordisk Investigational Site
Mexico City, , Mexico
Novo Nordisk Investigational Site
Alphen aan den Rijn, , Netherlands
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Bratislava, , Slovakia
Novo Nordisk Investigational Site
Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Malmo, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1132-1910
Identifier Type: OTHER
Identifier Source: secondary_id
INS-4019
Identifier Type: -
Identifier Source: org_study_id