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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628341
First Posted: June 26, 2012
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

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.


Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe) [ Time Frame: During the one-month follow-up after inclusion in study ]

Secondary Outcome Measures:
  • Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia [ Time Frame: During the last 12 months before inclusion in study ]
  • Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe) [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia [ Time Frame: During the last 12 months before inclusion in study ]
  • Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia [ Time Frame: 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 [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Overall/severe/non-severe hypoglycaemia episodes (event/patient/month) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life [ Time Frame: During the one-month follow-up after inclusion in study ]
  • Change in planned daily activities; work: effectiveness, missing hours or days for sick leave [ Time Frame: During the one-month follow-up after inclusion in study ]

Enrollment: 4424
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with diabetes (type 1 and 2) Drug: insulin
Patients will be asked to complete 2 self-assessment questionnaires

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628341


Locations
France
Novo Nordisk Investigational Site
Paris La défense cedex, France, 92932
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01628341     History of Changes
Other Study ID Numbers: INS-3988
U1111-1131-8540 ( Other Identifier: WHO )
First Submitted: June 22, 2012
First Posted: June 26, 2012
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs