Brief Summary

This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.

Trial Health

On Track

Trial Health Score

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

Enrollment

4,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach

6 countries

6 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

1 year study duration

Study Start

First participant enrolled

January 1, 2012

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed

Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

September 23, 2013

Last Update Submit

January 12, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire)
In the past 30 days prior to the day when responding to the online questionnaire
Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)
Day 1 (when responding to the online questionnaire)

Secondary Outcomes (3)

Incidence of intentional dosing irregularities and reasons for this behaviour
Day 1 (when responding to the online questionnaire)
Impact of dosing irregularity on functional well-being
Day 1 (when responding to the online questionnaire)
Frequency of self-treated hypoglycaemia
In the past 30 days prior to the day when responding to the online questionnaire

Study Arms (2)

Patients with type 2 diabetes mellitus (T2DM)

Behavioral: No treatment given

Healthcare professionals (HCPs)

Behavioral: survey

Interventions

No treatment givenBEHAVIORAL

Completion of 90-item online questionnaire.

Patients with type 2 diabetes mellitus (T2DM)

surveyBEHAVIORAL

Completion of 58-item online questionnarie.

Healthcare professionals (HCPs)

Eligibility Criteria

Sexall

Healthy VolunteersNo

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

Sampling MethodProbability Sample

Study Population

Insulin treated patients with type 2 diabetes, and HCPs involved in the treatment, management of diabetes and care of patients with type 2 diabetes.

You may qualify if:

PATIENTS WITH T2DM:
Diagnosed with type 2 diabetes by a healthcare professional
Currently being treated with insulin medication, excluding premix insulin treatment
Age at least 40 years
Diagnosed as having type 2 diabetes over the age of 40
HCPs:
Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator
Have a minimum of 2 years experience within current speciality
See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins

Contact the study team to confirm eligibility.