Easy Diabetes Treatment Study 1

NCT ID: NCT03258268

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-07
• Study Completion Date: 2019-12-19

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).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care with DSS

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.

Group Type: EXPERIMENTAL

Standard of Care with EASY DSS

Intervention Type: DEVICE

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.

Standard of Care without 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.

Group Type: ACTIVE_COMPARATOR

Standard of Care without EASY DSS

Intervention Type: OTHER

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.

Interventions

Standard 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.

Intervention Type: DEVICE

Standard 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Region Halland

OTHER

Sponsor Role: collaborator

Västra Götalandsregionen

OTHER

Sponsor Role: collaborator

Läkarexpressen AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damon Tojjar, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Region Halland

Hålland, , Sweden

Region Skåne

Skåne, , Sweden

Västra Götalandsregionen

Västra Götaland, , Sweden

Countries

Sweden

Other Identifiers

EASY-1

Identifier Type: -

Identifier Source: org_study_id