A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT02230631
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Part 1 (retrospective cross-sectional evaluation)	No treatment given	-
Part 2 (prospective observational evaluation)	No treatment given	-

Primary Outcome Measures

Name	Time	Method
The percentage of patients experiencing at least 1 hypoglycaemic event	During 4 weeks from baseline visit

Secondary Outcome Measures

Name	Time	Method
Difference in the reported incidence rates of hypoglycaemia	In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
Severe hypoglycaemic events	In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Non-severe hypoglycaemic events	In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Nocturnal hypoglycaemic events	In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
All hypoglycaemic events (any type)	In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Hypoglycaemic events requiring hospital admission	In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms	In the 4 weeks following the baseline visit (Patient Diary)
Documented symptomatic hypoglycaemic events	In the 4 weeks following the baseline visit (Patient Diary)