Clinical trial NCT01628341: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
Official title: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 4424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 3811 patients with Type 1 or Type 2 diabetes are expected to be recruited. Patients will be asked to complete 2 self-assessment questionnaires, one retrospective and one prospective, to characterize severe hypoglycaemias during the last 12 months (retrospective questionnaire) and severe/non-severe hypoglycaemias during the coming month after inclusion (prospective questionnaire).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
timeFrame: During the one-month follow-up after inclusion in study
Secondary outcomes:
measure: Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
timeFrame: During the last 12 months before inclusion in study
measure: Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
timeFrame: During the one-month follow-up after inclusion in study
measure: Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia
timeFrame: During the one-month follow-up after inclusion in study
measure: Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia
timeFrame: During the one-month follow-up after inclusion in study
measure: Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)
timeFrame: During the one-month follow-up after inclusion in study
measure: Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
timeFrame: During the last 12 months before inclusion in study
measure: Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
timeFrame: During the one-month follow-up after inclusion in study
measure: Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes
timeFrame: During the one-month follow-up after inclusion in study
measure: Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes
timeFrame: During the one-month follow-up after inclusion in study
measure: Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)
timeFrame: During the one-month follow-up after inclusion in study
measure: Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode)
timeFrame: During the one-month follow-up after inclusion in study
measure: Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver
timeFrame: During the one-month follow-up after inclusion in study
measure: Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life
timeFrame: During the one-month follow-up after inclusion in study
measure: Change in planned daily activities; work: effectiveness, missing hours or days for sick leave
timeFrame: During the one-month follow-up after inclusion in study
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Cariou B, Fontaine P, Eschwege E, Lievre 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 DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.