French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

N/ACompletedNCT01628341

Novo Nordisk A/S4,424 enrolled

Overview

This non-interventional study is conducted in Europe. The study is both retrospective and prospective. The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

Study Type

OBSERVATIONAL

Enrollment

4,424

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

Patients will be asked to complete 2 self-assessment questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Type 1 or Type 2 Diabetes Mellitus * Patients treated by insulin for at least 12 months * Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements * Patients able to complete the questionnaires * Patients who have accepted to participate to the survey (signature of an information notice) Exclusion Criteria: * Patients with Type 2 Diabetes Mellitus not treated with insulin * Females who are currently pregnant or lactating or who were pregnant during the previous year

Locations (1)

Novo Nordisk Investigational Site

Paris La Défense Cedex, France

Outcomes

Primary Outcomes

Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)

Time frame: During the one-month follow-up after inclusion in study

Secondary Outcomes

Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia

Time frame: During the last 12 months before inclusion in study

Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia

Time frame: During the one-month follow-up after inclusion in study

Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia

Time frame: During the one-month follow-up after inclusion in study

Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia

Time frame: During the one-month follow-up after inclusion in study

Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)

Time frame: During the one-month follow-up after inclusion in study

Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia

Time frame: During the last 12 months before inclusion in study

Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia

Time frame: During the one-month follow-up after inclusion in study

Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes

Data from ClinicalTrials.gov

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