Brief Summary

This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.

Trial Health

On Track

Trial Health Score

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

Enrollment

7,315

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach

8 countries

8 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

October 30, 2014

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed

21 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2015

Completed

Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

November 12, 2014

Last Update Submit

March 6, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

The percentage of patients who experience at least 1 hypoglycaemic episode
During the 4-week prospective observational period

Secondary Outcomes (18)

Incidence of any hypoglycaemic episodes
In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of hypoglycaemic episodes requiring hospital admission
In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of severe hypoglycaemic episodes
In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of non-severe hypoglycaemic episodes
In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of documented symptomatic hypoglycaemic episodes
In the 4 weeks after the baseline visit (day 1)
+13 more secondary outcomes

Study Arms (1)

SAQ-Self-Assessment Questionnaire

Other: No treatment given

Interventions

No treatment givenOTHER

This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.

SAQ-Self-Assessment Questionnaire

Eligibility Criteria

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

Male or female patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months who are 18 years or older, ambulatory, literate, and have signed the Informed Consent form may participate in the study.

You may qualify if:

Informed consent obtained before any trial-related activities
Patient with T1DM or T2DM treated with insulin for more than 12 months

You may not qualify if:

Previous participation in this study
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
Non-ambulatory patients
Simultaneous participation in any other clinical study with an investigational product

Contact the study team to confirm eligibility.