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Clinical Trial Details

Trial ID: L4505
Source ID: NCT01628341
Associated Drug: Insulin
Title: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients
Acronym: DIALOG
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin
Outcome Measures: 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|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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 4424
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2012-05
Completion Date: 2012-09
Results First Posted:
Last Update Posted: 2017-01-19
Locations: Novo Nordisk Investigational Site, Paris La défense cedex, 92932, France
URL: https://clinicaltrials.gov/show/NCT01628341