An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696266
• Other study ID #: INS-4019
• Secondary ID: U1111-1132-1910
• Status: Completed
• Start date: September 5, 2012
• Est. completion date: December 30, 2013

Study information

• Verified date: December 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29304
• Est. completion date: December 30, 2013
• Est. primary completion date: December 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Hypoglycemia

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Prov. De Buenos Aires
Austria	Novo Nordisk Investigational Site	Vienna
Bulgaria	Novo Nordisk Investigational Site	Sofia
Canada	Novo Nordisk Investigational Site	Mississauga
Croatia	Novo Nordisk Investigational Site	Zagreb
Czechia	Novo Nordisk Investigational Site	Prague
Denmark	Novo Nordisk Investigational Site	Copenhagen S
Finland	Novo Nordisk Investigational Site	Espoo
Germany	Novo Nordisk Investigational Site	Mainz
Hungary	Novo Nordisk Investigational Site	Budapest
India	Novo Nordisk Investigational Site	Bangalore
Israel	Novo Nordisk Investigational Site	Kfar Saba
Lebanon	Novo Nordisk Investigational Site	Amman
Malaysia	Novo Nordisk Investigational Site	Selangor Darul Ehsan
Mexico	Novo Nordisk Investigational Site	Mexico City
Netherlands	Novo Nordisk Investigational Site	Alphen A/d Rijn
Poland	Novo Nordisk Investigational Site	Warszawa
Romania	Novo Nordisk Investigational Site	Bucharest
Russian Federation	Novo Nordisk Investigational Site	Moscow
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Serbia	Novo Nordisk Investigational Site	Belgrade
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovenia	Novo Nordisk Investigational Site	Ljubljana
Sweden	Novo Nordisk Investigational Site	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Austria,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Finland,  Germany,  Hungary,  India,  Israel,  Lebanon,  Malaysia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Slovenia,  Sweden, 

References & Publications (11)

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 — View 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. — View 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. — View 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: Res — View 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 — View Citation

Kern W, Holstein A, Moenninghoff C, Kienhöfer 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. do — View Citation

Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters-Weijnen C, Forsén 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 hy — View Citation

Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters-Weijnen C, Forsén 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 pr — View 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 — View 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. D — View Citation

Pongrac Barlovic D, Zavratnik A, Skvarca A, Janša K, Vukelic B, Tomažic 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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any hypoglycaemic event		In the 4 weeks prior to and following the baseline visit (Week 0)
Secondary	Difference in the reported incidence rates of any hypoglycaemia		In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit
Secondary	Incidence of hypoglycaemic events requiring hospital admission		In the 6 months prior to and 4 weeks following the baseline visit
Secondary	Incidence of all severe hypoglycaemic events		In the 6 months prior to and 4 weeks following the baseline visit
Secondary	Incidence of probable symptomatic hypoglycaemic events		In the 4 weeks prior to and following the baseline visit

External Links

•   Clinical Trials at Novo Nordisk