A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

April 8, 2015 updated by: Novo Nordisk A/S
This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

704

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

  • Brazil
      • Säo Paulo, Brazil, 05001-400

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty-five sites will be selected, distributed in different regions of the country, in order to be representative of the Brazilian population.

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities
  • The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey

Exclusion Criteria:

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Illiterate patients and patients otherwise unable to 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Part 1 (retrospective cross-sectional evaluation)
Other: No treatment given
Two different questionnaires will be applied to patients during a regular clinical visit.
Part 2 (prospective observational evaluation)
Other: No treatment given
Two different questionnaires will be applied to patients during a regular clinical visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients experiencing at least 1 hypoglycaemic event
Time Frame: During 4 weeks from baseline visit
During 4 weeks from baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycaemic events requiring hospital admission
Time Frame: In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
Severe hypoglycaemic events
Time Frame: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Non-severe hypoglycaemic events
Time Frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Nocturnal hypoglycaemic events
Time Frame: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
Documented symptomatic hypoglycaemic events
Time Frame: In the 4 weeks following the baseline visit (Patient Diary)
In the 4 weeks following the baseline visit (Patient Diary)
Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms
Time Frame: In the 4 weeks following the baseline visit (Patient Diary)
In the 4 weeks following the baseline visit (Patient Diary)
All hypoglycaemic events (any type)
Time Frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Difference in the reported incidence rates of hypoglycaemia
Time Frame: In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit

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.

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

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4142
  • U1111-1147-4179 (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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