A Survey on Low Blod Sugar Among Insulin-treated Patients With Diabetes
NCT ID: NCT02306681
Last Updated: 2019-03-08
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
7315 participants
OBSERVATIONAL
2014-10-30
2015-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SAQ-Self-Assessment Questionnaire
No treatment given
This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.
Interventions
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No treatment given
This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.
Eligibility Criteria
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Inclusion Criteria
* Patient with T1DM or T2DM treated with insulin for more than 12 months
* Male or female patient at least 18 years of age at the time of inclusion in the study
Exclusion Criteria
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
* Non-ambulatory patients
* Simultaneous participation in any other clinical study with an investigational product
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
Dhaka, , Bangladesh
Novo Nordisk Investigational Site
Bogotá, , Colombia
Novo Nordisk Investigational Site
Cairo, , Egypt
Novo Nordisk Investigational Site
Manila, , Philippines
Novo Nordisk Investigational Site
Singapore, , Singapore
Novo Nordisk Investigational Site
Pretoria, , South Africa
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Ajman, , United Arab Emirates
Countries
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References
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Pathan F, Goh SY, Rudijanto A, Gadekar A, Jain A, Nicodemus N Jr. Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study. J ASEAN Fed Endocr Soc. 2018;33(1):28-36. doi: 10.15605/jafes.033.01.05. Epub 2018 Apr 4.
Emral R, Pathan F, Cortes CAY, El-Hefnawy MH, Goh SY, Gomez AM, Murphy A, Abusnana S, Rudijanto A, Jain A, Ma Z, Mirasol R; IO HAT Investigator Group. Self-reported hypoglycemia in insulin-treated patients with diabetes: Results from an international survey on 7289 patients from nine countries. Diabetes Res Clin Pract. 2017 Dec;134:17-28. doi: 10.1016/j.diabres.2017.07.031. Epub 2017 Aug 9.
Emral R, Tetiker T, Sahin I, Sari R, Kaya A, Yetkin I, Cil SU, Tutuncu NB; IO HAT investigator group. An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study. BMC Endocr Disord. 2018 Feb 13;18(1):9. doi: 10.1186/s12902-018-0238-2.
Pathan MF, Fariduddin M, Nazimuddin K, Mollah AS, Islam Siddiqui MN, Hassan KA, Ferdous HS, Rahman MH, Ashrafuzzaman SM, Sobhan MJ, E-Tanvir Haider MR, Amin MF. The Incidence of Hypoglycemia among Insulin-Treated Patients with Type 1 or Type 2 Diabetes: Bangladeshi Cohort of International Operations-Hypoglycemia Assessment Tool Study. Indian J Endocrinol Metab. 2018 May-Jun;22(3):379-386. doi: 10.4103/ijem.IJEM_545_17.
Mirasol R, Nicodemus N Jr, Jain A, Gadekar AV, Yu-Gan S. Self-Reported Hypoglycemia in Insulin-Treated Patients with Diabetes: Results from the Philippine Cohort of the International Operations Hypoglycemia Assessment Tool (IO HAT) Study. J ASEAN Fed Endocr Soc. 2018;33(1):12-21. doi: 10.15605/jafes.033.01.03. Epub 2018 Apr 3.
Gomez AM, Chica LG, Burbano AF, Vasquez EM, Escobar JA, Arias PM, Molina DI. Survey on hypoglycemia among insulin-treated patients with diabetes: The Colombian International Operations Hypoglycemia Assessment Tool population. Biomedica. 2019 Sep 1;39(3):576-586. doi: 10.7705/biomedica.4365.
Rudijanto A, Saraswati MR, Yunir E, Kumala P, Puteri HH, Mandang VV. Indonesia Cohort of IO HAT Study to Evaluate Diabetes Management, Control, and Complications in Retrospective and Prospective Periods Among Insulin-Treated Patients with Type 1 and Type 2 Diabetes. Acta Med Indones. 2018 Jan;50(1):26-37.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1161-9157
Identifier Type: OTHER
Identifier Source: secondary_id
INS-4177
Identifier Type: -
Identifier Source: org_study_id
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