A Survey on Low Blod Sugar Among Insulin-treated Patients With Diabetes

March 6, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Novo Nordisk Investigational Site
  • Colombia
      • Bogotá, Colombia, 1
        • Novo Nordisk Investigational Site
  • Egypt
      • Cairo, Egypt
        • Novo Nordisk Investigational Site
  • Philippines
      • Manilla, Philippines, 1605
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novo Nordisk Investigational Site
  • South Africa
      • Pretoria, South Africa, 2
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
  • United Arab Emirates
      • Ajman, United Arab Emirates, 21499
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SAQ-Self-Assessment Questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients who experience at least 1 hypoglycaemic episode
Time Frame: During the 4-week prospective observational period
During the 4-week prospective observational period

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of any hypoglycaemic episodes
Time Frame: In the 4 weeks before and 4 weeks after the baseline (day 1)
In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of hypoglycaemic episodes requiring hospital admission
Time Frame: In the 6 months before and 4 weeks after the baseline (day 1)
In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of severe hypoglycaemic episodes
Time Frame: In the 6 months before and 4 weeks after the baseline (day 1)
In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of non-severe hypoglycaemic episodes
Time Frame: In the 4 weeks before and 4 weeks after the baseline (day 1)
In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of documented symptomatic hypoglycaemic episodes
Time Frame: In the 4 weeks after the baseline visit (day 1)
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
Time Frame: In the 4 weeks following the baseline visit (day 1)
In the 4 weeks following the baseline visit (day 1)
Incidence of hypoglycaemic episodes
Time Frame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
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
Time Frame: In the 4 weeks following the baseline visit (day 1)
In the 4 weeks following the baseline visit (day 1)
Frequency of blood glucose monitoring
Time Frame: Over 1 day
Over 1 day
Patient reported fear of hypoglycaemia
Time Frame: Over one day
Over one day
Patient reported recovery times
Time Frame: One day
One day
Proportion of patients consulting a doctor
Time Frame: Over one day
Over one day
Proportion of patients increasing calorie intake
Time Frame: Over one day
Over one day
Proportion of patients avoiding physical exercise
Time Frame: Over one day
Over one day
Proportion of patients reducing or skipping insulin dose
Time Frame: Over one day
Over one day
Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes
Time Frame: Over one day
Over one day
Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes
Time Frame: Over one day
Over one day
DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores
Time Frame: Over last 4 weeks
Over last 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2014

Primary Completion (Actual)

May 14, 2015

Study Completion (Actual)

May 14, 2015

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4177
  • U1111-1161-9157 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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