A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

NCT02230631 | Completed

• 2 other identifiers: INS-4142U1111-1147-4179
• Study Type: observational
• Target: 704
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The percentage of patients experiencing at least 1 hypoglycaemic event

  During 4 weeks from baseline visit

Secondary Outcomes (8)

• Hypoglycaemic events requiring hospital admission

  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

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

• Non-severe hypoglycaemic events

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

• Nocturnal hypoglycaemic events

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

• Documented symptomatic hypoglycaemic events

  In the 4 weeks following the baseline visit (Patient Diary)

Study Arms (2)

Part 1 (retrospective cross-sectional evaluation)

Other: No treatment given

Part 2 (prospective observational evaluation)

Other: No treatment given

Interventions

No treatment given OTHER

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

Part 1 (retrospective cross-sectional evaluation); Part 2 (prospective observational evaluation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Informed consent obtained before any study-related activities

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Säo Paulo, 05001-400, Brazil

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

BR (1)