A Survey on Low Blod Sugar 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: NCT02306681
• Other study ID #: INS-4177
• Secondary ID: U1111-1161-9157
• Status: Completed
• Start date: October 30, 2014
• Est. completion date: May 14, 2015

Study information

• Verified date: March 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7315
• Est. completion date: May 14, 2015
• Est. primary completion date: May 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Bangladesh	Novo Nordisk Investigational Site	Dhaka
Colombia	Novo Nordisk Investigational Site	Bogotá
Egypt	Novo Nordisk Investigational Site	Cairo
Philippines	Novo Nordisk Investigational Site	Manilla
Singapore	Novo Nordisk Investigational Site	Singapore
South Africa	Novo Nordisk Investigational Site	Pretoria
Turkey	Novo Nordisk Investigational Site	Ankara
United Arab Emirates	Novo Nordisk Investigational Site	Ajman

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bangladesh,  Colombia,  Egypt,  Philippines,  Singapore,  South Africa,  Turkey,  United Arab Emirates, 

References & Publications (4)

Emral R, Pathan F, Cortés CAY, El-Hefnawy MH, Goh SY, Gómez 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 surv — View Citation

Emral R, Tetiker T, Sahin I, Sari R, Kaya A, Yetkin I, Cil SU, Tütüncü 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. — View Citation

Faruque Pathan, Su-Yen Goh, Achmad Rudijanto, Arvind Gadekar, Anand Jain, Nemencio Nicodemus Jr. Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study Journal of the ASEAN Federation of Endocrine Societies

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: B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who experience at least 1 hypoglycaemic episode		During the 4-week prospective observational period
Secondary	Incidence of any hypoglycaemic episodes		In the 4 weeks before and 4 weeks after the baseline (day 1)
Secondary	Incidence of hypoglycaemic episodes requiring hospital admission		In the 6 months before and 4 weeks after the baseline (day 1)
Secondary	Incidence of severe hypoglycaemic episodes		In the 6 months before and 4 weeks after the baseline (day 1)
Secondary	Incidence of non-severe hypoglycaemic episodes		In the 4 weeks before and 4 weeks after the baseline (day 1)
Secondary	Incidence of documented symptomatic hypoglycaemic episodes		In the 4 weeks after the baseline visit (day 1)
Secondary	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)
Secondary	Incidence of hypoglycaemic episodes		Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
Secondary	Incidence of probable symptomatic hypoglycaemia		In the 4 weeks following the baseline visit (day 1)
Secondary	Frequency of blood glucose monitoring		Over 1 day
Secondary	Patient reported fear of hypoglycaemia		Over one day
Secondary	Patient reported recovery times		One day
Secondary	Proportion of patients consulting a doctor		Over one day
Secondary	Proportion of patients increasing calorie intake		Over one day
Secondary	Proportion of patients avoiding physical exercise		Over one day
Secondary	Proportion of patients reducing or skipping insulin dose		Over one day
Secondary	Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes		Over one day
Secondary	Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes		Over one day
Secondary	DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores		Over last 4 weeks

External Links

•   Clinical Trials at Novo Nordisk