Skip to main content
OpenTrials
Completed

NCT Number: NCT02230631

A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Säo Paulo, 05001-400, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Two different questionnaires will be applied to patients during a regular clinical visit.

Primary outcomes

  1. The percentage of patients experiencing at least 1 hypoglycaemic event

    Time frame: During 4 weeks from baseline visit

Secondary outcomes

  1. 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

  2. Severe hypoglycaemic events

    Time frame: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit

  3. 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

  4. Nocturnal hypoglycaemic events

    Time frame: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit

  5. Documented symptomatic hypoglycaemic events

    Time frame: In the 4 weeks following the baseline visit (Patient Diary)

  6. 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)

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 3, 2014
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.