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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1161-9157 | Other Identifier | WHO |
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This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAQ-Self-Assessment Questionnaire |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who experience at least 1 hypoglycaemic episode | During the 4-week prospective observational period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any hypoglycaemic episodes | In the 4 weeks before and 4 weeks after the baseline (day 1) | |
| Incidence of hypoglycaemic episodes requiring hospital admission | In the 6 months before and 4 weeks after the baseline (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months who are 18 years or older, ambulatory, literate, and have signed the Informed Consent form may participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Dhaka | 1000 | Bangladesh | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33442108 | Background | 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. | |
| 28951336 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Incidence of severe hypoglycaemic episodes | In the 6 months before and 4 weeks after the baseline (day 1) |
| Incidence of non-severe hypoglycaemic episodes | In the 4 weeks before and 4 weeks after the baseline (day 1) |
| Incidence of documented symptomatic hypoglycaemic episodes | In the 4 weeks after the baseline visit (day 1) |
| Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms | In the 4 weeks following the baseline visit (day 1) |
| Incidence of hypoglycaemic episodes | Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1) |
| Incidence of probable symptomatic hypoglycaemia | In the 4 weeks following the baseline visit (day 1) |
| Frequency of blood glucose monitoring | Over 1 day |
| Patient reported fear of hypoglycaemia | Over one day |
| Patient reported recovery times | One day |
| Proportion of patients consulting a doctor | Over one day |
| Proportion of patients increasing calorie intake | Over one day |
| Proportion of patients avoiding physical exercise | Over one day |
| Proportion of patients reducing or skipping insulin dose | Over one day |
| Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes | Over one day |
| Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes | Over one day |
| DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores | Over last 4 weeks |
| Bogotá |
| 1 |
| Colombia |
| Novo Nordisk Investigational Site | Cairo | Egypt |
| Novo Nordisk Investigational Site | Manila | 1605 | Philippines |
| Novo Nordisk Investigational Site | Singapore | 169608 | Singapore |
| Novo Nordisk Investigational Site | Pretoria | 2 | South Africa |
| Novo Nordisk Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Ajman | 21499 | United Arab Emirates |
| 29433560 | Result | 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. |
| 30090731 | Result | 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. |
| 33442106 | Derived | 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. |
| 31584770 | Derived | 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. |
| 29686173 | Derived | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |