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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with diabetes (type 1 and 2)<br> | Drug: insulin<br>* Patients will be asked to complete 2 self-assessment questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia |  | During the last 12 months before 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 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 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 last 12 months before 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 |