DiabetesCONFIDENCENCT01542476
The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 299 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2006to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Being tested
- insulin detemir
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
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
| Study group | Role | What they receive |
|---|---|---|
| IDet users | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)
Measured: Baseline, month 6
Secondary outcomes (6)
Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)
Measured: Baseline, month 6
Change in HbA1c (glycosylated haemoglobin)
Measured: Baseline, month 6
Change in Fasting blood glucose (FBG)
Measured: Baseline, month 6
Change in body weight
Measured: Baseline, month 6
Hypoglycaemic episodes
Measured: Month 6
Adverse events
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startAug 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542476
- Sponsor's protocol ID
- NN304-1924
- Acronym
- CONFIDENCE
- Status last verified
- Mar 2016
- First submitted
- 24 Feb 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01542476
- Acronym / sponsor ID
- CONFIDENCE / NN304-1924
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDet users | – | Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin detemirPrescribed 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 | Drug | IDet users |
Primary outcome
Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)
Time frame: Baseline, month 6
6 secondary outcomes
Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)
Time frame: Baseline, month 6
Change in HbA1c (glycosylated haemoglobin)
Time frame: Baseline, month 6
Change in Fasting blood glucose (FBG)
Time frame: Baseline, month 6
Change in body weight
Time frame: Baseline, month 6
Hypoglycaemic episodes
Time frame: Month 6
Adverse events
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS) (time frame: Baseline, month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.