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

NCT ID: NCT01628341

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4424 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with diabetes (type 1 and 2)

insulin

Intervention Type DRUG

Patients will be asked to complete 2 self-assessment questionnaires

Interventions

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insulin

Patients will be asked to complete 2 self-assessment questionnaires

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Paris La Défense Cedex, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25465273 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1131-8540

Identifier Type: OTHER

Identifier Source: secondary_id

INS-3988

Identifier Type: -

Identifier Source: org_study_id

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