Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.
Interventions
DRUGInsulin degludec
Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.
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 * Male or female age greater than or equal to 18 years at the time of insulin degludec initiation * Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients * Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection * Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec * At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation * Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)
Exclusion criteria
* Previous participation in this study. Participation is defined as having signed the Informed Consent in this study * Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | measured in % point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percentage of patients with HbA1c below 7.5% | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | percentage of patients |
| Change in percentage of patients with HbA1c below 8.0% | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | percentage of patients |
| Change in the mean Fasting Plasma Glucose (FPG) | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | measured in mmol/L |
| Insulin degludec dose | At switch to insulin degludec (week 0) | measured in units/day |
| Change in the mean daily insulin doses (total, basal, prandial) | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | measured in units/day |
| Change in the number of concomitant non-insulin glucose-lowering drug classes | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | number of concomitant non-insulin glucose-lowering drug classes |
| Change in percentage of patients with HbA1c below 7% | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | percentage of patients |
| Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe) | Before change to insulin degludec (-6 to 0 months) | percentage of patients |
| Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) | Before change to insulin degludec (-6 to 0 months) | rates of hypoglycaemic episodes |
| Percentage of patients continuing insulin degludec | After change to insulin degludec (0 to 6 months) | percentage of patients |
| Reason(s) for starting insulin degludec | At time of switch to insulin degludec (week 0) | Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other |
| Reason(s) for discontinuing insulin degludec | At time of discontinuing insulin degludec (0 to 6 months) | Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other |
| Change in body weight | Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec | measured in kg |
Countries
Canada
Outcome results
None listed