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OpenTrials
Completed

NCT Number: NCT01542476

The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Alphen aan den Rijn, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

insulin detemir

Drug

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

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)

    Time frame: Baseline, month 6

Secondary outcomes

  1. Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)

    Time frame: Baseline, month 6

  2. Change in HbA1c (glycosylated haemoglobin)

    Time frame: Baseline, month 6

  3. Change in Fasting blood glucose (FBG)

    Time frame: Baseline, month 6

  4. Change in body weight

    Time frame: Baseline, month 6

  5. Hypoglycaemic episodes

    Time frame: Month 6

  6. Adverse events

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: CONFIDENCE

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 2, 2012
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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