Type 2 Diabetes Mellitus
Conditions
Brief summary
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
Interventions
DEVICEStandard of Care with EASY DSS
The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
OTHERStandard of Care without EASY DSS
Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
Sponsors
Region Skane
Lund University
Region Halland
Västra Götalandsregionen
Läkarexpressen AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
Intervention model description
Multicenter, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * ≥ 18 years of age at the time of signing informed consent * Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening * HbA1c ≥ 7.0 \[58 mmol/mol\] by central laboratory analysis * Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
Exclusion criteria
* Previous participation in this trial. Participation is defined as informed consent. * Currently participating in other clinical trials for diabetes * Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies * History of diabetic ketoacidosis or hyperosmolar hyperglycemic state * Corticosteroid-induced or pancreatitis-induced diabetes * History of chronic or acute pancreatitis * Known or suspected substance abuse * Pregnancy * Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins) * Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) * Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate \< 15 mL/min/1.73m2 * Recent or planned major surgery (such as gastric bypass operation) * Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel * Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 26 weeks | Change from baseline HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose | 26 weeks | Change from baseline in fasting plasma glucose (FPG) |
| Achieving treatment target | 26 weeks | Meeting treatment target of HbA1c \< 7% (53 mmol/mol) |
| Hypoglycemia | 26 weeks | Meeting treatment target of HbA1c \< 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes |
Countries
Sweden
Outcome results
None listed