Easy Diabetes Treatment Study 1

Study Overview
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Brief Summary
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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).

Official Title
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A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Standard of Care with EASY DSS
* Other: Standard of Care without EASY DSS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care with DSS<br>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. | Device: Standard of Care with EASY DSS<br>* 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.<br>|
| Active Comparator: Standard of Care without DSS<br>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. | Other: Standard of Care without EASY DSS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change from baseline HbA1c | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose | Change from baseline in fasting plasma glucose (FPG) | 26 weeks | 
| Achieving treatment target | Meeting treatment target of HbA1c < 7% (53 mmol/mol) | 26 weeks | 
| Hypoglycemia | Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes | 26 weeks |