Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin
Patients will be asked to complete 2 self-assessment questionnaires
Sponsors
Novo Nordisk A/S
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 non-severe symptomatic 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 non-severe symptomatic hypoglycaemia episodes | 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 |
| 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 |
| Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes | During the one-month follow-up after inclusion in study |
Countries
France
Outcome results
None listed