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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings