Clinical trial NCT01696266: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Official title: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-09-28
Enrollment: 29304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
* Patients giving informed consent to participate in the survey

Exclusion Criteria:

* Non-ambulatory patients
* Illiterate patients and patients otherwise unable to complete a written survey

Primary outcomes:
measure: Incidence of any hypoglycaemic event
timeFrame: In the 4 weeks prior to and following the baseline visit (Week 0)
Secondary outcomes:
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
Other outcomes:
Locations:
city: Prov. De Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Vienna
country: Austria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Prague
country: Czechia
facility: Novo Nordisk Investigational Site
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
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
city: Alphen A/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.