The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction
CONFIDENCE
An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch ExperieNCE)
1 other identifier
observational
299
1 country
1
Brief Summary
This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2006
1 active site
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
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 24, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedMarch 3, 2016
March 1, 2016
1.2 years
February 24, 2012
March 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)
Baseline, month 6
Secondary Outcomes (6)
Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)
Baseline, month 6
Change in HbA1c (glycosylated haemoglobin)
Baseline, month 6
Change in Fasting blood glucose (FBG)
Baseline, month 6
Change in body weight
Baseline, month 6
Hypoglycaemic episodes
Month 6
- +1 more secondary outcomes
Study Arms (1)
IDet users
Interventions
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
Eligibility Criteria
Any subject with type 1 or type 2 diabetes not optimally controlled in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
You may qualify if:
- Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
- Subjects with type 1 diabetes should have been treated with insulin for at least 12 months
- Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Alphen aan den Rijn, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2012
First Posted
March 2, 2012
Study Start
August 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 3, 2016
Record last verified: 2016-03