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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin

• Registration Number: NCT01628341
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-26
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4424

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diabetes (type 1 and 2)	insulin	-

Primary Outcome Measures

Name	Time	Method
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)	During the one-month follow-up after inclusion in study

Secondary Outcome Measures

Name	Time	Method
Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia	During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia	During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia	During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)	During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia	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	During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes	During the one-month follow-up after inclusion in study
Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)	During the one-month follow-up after inclusion in study
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
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
Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life	During the one-month follow-up after inclusion in study
Change in planned daily activities; work: effectiveness, missing hours or days for sick leave	During the one-month follow-up after inclusion in study

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris La défense cedex, France