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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

29,304

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2012

Geographic Reach

22 countries

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

September 5, 2012

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2013

Completed

Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

September 26, 2012

Last Update Submit

December 7, 2018

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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

Study Arms (1)

Insulin-treated patients with diabetes

Other: No treatment given

Interventions

No treatment givenOTHER

Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).

Insulin-treated patients with diabetes

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Insulin-treated patients with Type 1 or Type 2 diabetes mellitus. Patients should be ambulatory, literate, have used insulin for at least 12 months, and be over 18 years of age to be able to participate in the study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.