A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

NCT ID: NCT02230631

Last Updated: 2015-04-09

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

704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with 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

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Part 1 (retrospective cross-sectional evaluation)

No treatment given

Intervention Type OTHER

Two different questionnaires will be applied to patients during a regular clinical visit.

Part 2 (prospective observational evaluation)

No treatment given

Intervention Type OTHER

Two different questionnaires will be applied to patients during a regular clinical visit.

Interventions

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No treatment given

Two different questionnaires will be applied to patients during a regular clinical visit.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any study-related activities
* The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey

Exclusion Criteria

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Illiterate patients and patients otherwise unable to complete a written survey
* Non-ambulatory patients
* Simultaneous participation in any other clinical study with an investigational product
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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Säo Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1147-4179

Identifier Type: OTHER

Identifier Source: secondary_id

INS-4142

Identifier Type: -

Identifier Source: org_study_id

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