A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Novo Nordisk A/S704 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

704

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

No treatment givenOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Säo Paulo, Brazil

Outcomes

Primary Outcomes

The percentage of patients experiencing at least 1 hypoglycaemic event

Time frame: During 4 weeks from baseline visit

Secondary Outcomes

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

Severe hypoglycaemic events

Time frame: 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

Nocturnal hypoglycaemic events

Time frame: 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)

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)

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

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

Data from ClinicalTrials.gov

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