Clinical trial NCT02306681: A Survey on Low Blod Sugar 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: 2014-12-03
Enrollment: 7315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* 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:

* Previous participation in this study
* 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

Primary outcomes:
measure: The percentage of patients who experience at least 1 hypoglycaemic episode
timeFrame: During the 4-week prospective observational period
Secondary outcomes:
measure: Incidence of any hypoglycaemic episodes
timeFrame: In the 4 weeks before and 4 weeks after the baseline (day 1)
measure: Incidence of hypoglycaemic episodes requiring hospital admission
timeFrame: In the 6 months before and 4 weeks after the baseline (day 1)
measure: Incidence of severe hypoglycaemic episodes
timeFrame: In the 6 months before and 4 weeks after the baseline (day 1)
measure: Incidence of non-severe hypoglycaemic episodes
timeFrame: In the 4 weeks before and 4 weeks after the baseline (day 1)
measure: Incidence of documented symptomatic hypoglycaemic episodes
timeFrame: In the 4 weeks after the baseline visit (day 1)
measure: Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms
timeFrame: In the 4 weeks following the baseline visit (day 1)
measure: Incidence of hypoglycaemic episodes
timeFrame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
measure: Incidence of probable symptomatic hypoglycaemia
timeFrame: In the 4 weeks following the baseline visit (day 1)
measure: Frequency of blood glucose monitoring
timeFrame: Over 1 day
measure: Patient reported fear of hypoglycaemia
timeFrame: Over one day
measure: Patient reported recovery times
timeFrame: One day
measure: Proportion of patients consulting a doctor
timeFrame: Over one day
measure: Proportion of patients increasing calorie intake
timeFrame: Over one day
measure: Proportion of patients avoiding physical exercise
timeFrame: Over one day
measure: Proportion of patients reducing or skipping insulin dose
timeFrame: Over one day
measure: Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes
timeFrame: Over one day
measure: Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes
timeFrame: Over one day
measure: DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores
timeFrame: Over last 4 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Novo Nordisk Investigational Site
city: Bogotá
country: Colombia
facility: Novo Nordisk Investigational Site
city: Cairo
country: Egypt
facility: Novo Nordisk Investigational Site
city: Manilla
country: Philippines
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ajman
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.