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

NCT01628341 | Completed

• 2 other identifiers: INS-3988U1111-1131-8540
• Study Type: observational
• Target: 4,424
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)

  During the one-month follow-up after inclusion in study

Secondary Outcomes (14)

• 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

Study Arms (1)

Patients with diabetes (type 1 and 2)

Drug: insulin

Interventions

insulin DRUG

Patients will be asked to complete 2 self-assessment questionnaires

Patients with diabetes (type 1 and 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Related Publications (1)

• Cariou B, Fontaine P, Eschwege E, Lievre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.

  PMID: 25465273 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

FR (1)