An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Completed

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

• Registration Number: NCT01696266
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-05
• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2013-12-30
• Study Completion: 2013-12-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29304

Inclusion Criteria

• Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
• Patients giving informed consent to participate in the survey

Read More

Exclusion Criteria

• Non-ambulatory patients
• Illiterate patients and patients otherwise unable to complete a written survey

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin-treated patients with diabetes	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Incidence of any hypoglycaemic event	In the 4 weeks prior to and following the baseline visit (Week 0)

Secondary Outcome Measures

Name	Time	Method
Incidence of probable symptomatic hypoglycaemic events	In the 4 weeks prior to and following the baseline visit
Incidence of all severe hypoglycaemic events	In the 6 months prior to and 4 weeks following the baseline visit
Incidence of hypoglycaemic events requiring hospital admission	In the 6 months prior to and 4 weeks following the baseline visit
Difference in the reported incidence rates of any hypoglycaemia	In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Malmö, Sweden