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NCT01628341 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— DIALOG  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01628341
Other study ID # INS-3988
Secondary ID U1111-1131-8540
Status Completed
Phase N/A
First received June 22, 2012
Last updated January 18, 2017
Start date May 2012
Est. completion date September 2012

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 4424
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin
Patients will be asked to complete 2 self-assessment questionnaires

Locations
Country Name City State
France Novo Nordisk Investigational Site Paris La défense cedex

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (1)

Cariou B, Fontaine P, Eschwege E, Lièvre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DI — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe) During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia During the last 12 months before inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe) During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia During the last 12 months before inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes During the one-month follow-up after inclusion in study
Secondary Overall/severe/non-severe hypoglycaemia episodes (event/patient/month) During the one-month follow-up after inclusion in study
Secondary Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode) During the one-month follow-up after inclusion in study
Secondary Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver During the one-month follow-up after inclusion in study
Secondary Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life During the one-month follow-up after inclusion in study
Secondary Change in planned daily activities; work: effectiveness, missing hours or days for sick leave During the one-month follow-up after inclusion in study
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