A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

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

Overall Status Completed
Start Date October 2014
Completion Date March 2015
Primary Completion Date March 2015
Study Type Observational
Primary Outcome
Measure Time Frame
The percentage of patients experiencing at least 1 hypoglycaemic event During 4 weeks from baseline visit
Secondary Outcome
Measure Time Frame
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)
Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms In the 4 weeks following the baseline visit (Patient Diary)
All hypoglycaemic events (any type) 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 In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
Enrollment 704
Condition
Intervention

Intervention type: Other

Intervention name: No treatment given

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

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility
Location Countries

Brazil

Verification Date

April 2015

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Part 1 (retrospective cross-sectional evaluation)

Arm group label: Part 2 (prospective observational evaluation)

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov