Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus. EU-TREAT (EUropean TREsiba AudiT)
Interventions
OTHERNo treatment given
Information will be collected from the medical records (paper/electronic) of each patient at several outpatient clinics to describe the two periods of medical history: before and after the initiation date of Tresiba®. For each patient, data will be collected, to describe a minimum of 6 months to a maximum of 12 months in each period; thus, the study will collect information on 12 to 24 months of medical history for each patient.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient * Age at least 18 years at the time of Tresiba® initiation * T1DM or insulin-treated T2DM patients * Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection * Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba® * At least one documented medical visit in the first 9 months after Tresiba® initiation * Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months
Exclusion criteria
* Previous participation in this study. Participation is defined as having signed the Informed Consent * Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba® * Current participation in another non-interventional study on insulin degludec (Tresiba®) * Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c after switch to Tresiba® | Month 0, Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c after switch to Tresiba® | Month 0, Month 12 |
| Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® | Month 0, Month 6 |
| Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® | Month 0, Month 6 |
| Change in the mean FPG level after switch to Tresiba® | Month 0, Month 12 |
| Tresiba® starting dose at switch and doses | At 6 months |
| Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® | Month 0, Month 6 |
| Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 |
| Change in body weight (kg) after switch to Tresiba® | Month 0, Month 6 |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 |
| Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months |
| Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba® | -6 to 0 months (ie 6 months before switch to Tresiba®) |
| Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months |
| Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® |
| Percentage of patients continuing Tresiba® post-switch | At 6 months |
| Reason(s) for starting Tresiba®, if available | Month 0, Month 12 |
| Reason(s) for discontinuing Tresiba®, if applicable and available | Month 0, Month 12 |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | -6 to 0 months ie 6 months before switch to Tresiba® |
Countries
Austria, Denmark, Germany, Greece, Italy, Switzerland
Outcome results
None listed