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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01628341
First received: June 22, 2012
Last updated: July 29, 2013
Last verified: July 2013
  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: No treatment given

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia [ Time Frame: During the one-month follow-up after inclusion in study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia [ Time Frame: During the one-month follow-up after inclusion in study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia [ Time Frame: During the last 12 months before inclusion in study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall/severe/non-severe hypoglycaemia episodes (event/patient/month) [ Time Frame: During the one-month follow-up after inclusion in study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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: No treatment given
Patients will be asked to complete 2 self-assessment questionnaires

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628341

Locations
France
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01628341     History of Changes
Other Study ID Numbers: INS-3988, U1111-1131-8540
Study First Received: June 22, 2012
Last Updated: July 29, 2013
Health Authority: France: Not required for observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014