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

Novo Nordisk A/S1 site in 1 country7,315 target enrollmentOctober 30, 2014

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 7315
Locations: 1
Primary Endpoint: The percentage of patients who experience at least 1 hypoglycaemic episode
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 30, 2014

End Date

May 14, 2015

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

The percentage of patients who experience at least 1 hypoglycaemic episode

Time Frame: During the 4-week prospective observational period

Secondary Outcomes

Patient reported fear of hypoglycaemia(Over one day)
Incidence of documented symptomatic hypoglycaemic episodes(In the 4 weeks after the baseline visit (day 1))
Incidence of probable symptomatic hypoglycaemia(In the 4 weeks following the baseline visit (day 1))
Incidence of hypoglycaemic episodes requiring hospital admission(In the 6 months before and 4 weeks after the baseline (day 1))
Frequency of blood glucose monitoring(Over 1 day)
Patient reported recovery times(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)
Incidence of severe hypoglycaemic episodes(In the 6 months before and 4 weeks after the baseline (day 1))
Proportion of patients consulting a doctor(Over one day)
Incidence of any hypoglycaemic episodes(In the 4 weeks before and 4 weeks after the baseline (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))
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)
Incidence of non-severe hypoglycaemic episodes(In the 4 weeks before and 4 weeks after the baseline (day 1))