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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: April 29, 2014
Last verified: April 2014
  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 ] [ 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: insulin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 29, 2014
Health Authority: France: Not required for observational study

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

ClinicalTrials.gov processed this record on November 20, 2014