A Survey on Low Blod Sugar Among Insulin-treated Patients With Diabetes

Novo Nordisk A/S7,315 enrolled

Overview

This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.

Study Type

OBSERVATIONAL

Enrollment

7,315

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

No treatment givenOTHER

This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained before any trial-related activities * Patient with T1DM or T2DM treated with insulin for more than 12 months * Male or female patient at least 18 years of age at the time of inclusion in the study Exclusion Criteria: * Previous participation in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey * Non-ambulatory patients * Simultaneous participation in any other clinical study with an investigational product

Locations (8)

Novo Nordisk Investigational Site

Dhaka, Bangladesh

Novo Nordisk Investigational Site

Bogotá, Colombia

Novo Nordisk Investigational Site

Cairo, Egypt

Novo Nordisk Investigational Site

Manila, Philippines

Outcomes

Primary Outcomes

The percentage of patients who experience at least 1 hypoglycaemic episode

Time frame: During the 4-week prospective observational period

Secondary Outcomes

Incidence of any hypoglycaemic episodes

Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)

Incidence of hypoglycaemic episodes requiring hospital admission

Time frame: In the 6 months before and 4 weeks after the baseline (day 1)

Incidence of severe hypoglycaemic episodes

Time frame: In the 6 months before and 4 weeks after the baseline (day 1)

Incidence of non-severe hypoglycaemic episodes

Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)

Incidence of documented symptomatic hypoglycaemic episodes

Time frame: In the 4 weeks after the baseline visit (day 1)

Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms

Time frame: In the 4 weeks following the baseline visit (day 1)

Incidence of hypoglycaemic episodes

Time frame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)

Incidence of probable symptomatic hypoglycaemia

Time frame: In the 4 weeks following the baseline visit (day 1)

Frequency of blood glucose monitoring

Data from ClinicalTrials.gov

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