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Completed

NCT Number: NCT01628341

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

Patients will be asked to complete 2 self-assessment questionnaires

Primary outcomes

  1. 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 outcomes

  1. Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia

    Time frame: During the last 12 months before inclusion in study

  2. Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia

    Time frame: During the one-month follow-up after inclusion in study

  3. 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

  4. Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia

    Time frame: During the one-month follow-up after inclusion in study

  5. 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

  6. Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia

    Time frame: During the last 12 months before inclusion in study

  7. 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

  8. 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

  9. 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

  10. Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)

    Time frame: During the one-month follow-up after inclusion in study

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: DIALOG

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 26, 2012
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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