Easy Diabetes Treatment Study 1 (EASY-1)

• ClinicalTrials.gov Identifier: NCT03258268
• Recruitment Status: Completed
• First Posted: August 23, 2017
• Last Update Posted: October 5, 2020
• Sponsor: Läkarexpressen AB
• Collaborators: Region Skane; Lund University; Region Halland; Västra Götalandsregionen
• Information provided by (Responsible Party): Läkarexpressen AB

Tracking Information

• First Submitted Date: August 20, 2017
• First Posted Date: August 23, 2017
• Last Update Posted Date: October 5, 2020
• Actual Study Start Date: August 7, 2017
• Actual Primary Completion Date: December 12, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2017)

HbA1c [ Time Frame: 26 weeks ]

Change from baseline HbA1c

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 20, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Easy Diabetes Treatment Study 1
• Official Title: A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multicenter, randomized controlled trial

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.

Primary Purpose: Treatment

• Condition: Type 2 Diabetes Mellitus

Intervention

• Device: 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.

• Other: 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.

Study Arms

• Experimental: 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.

  Intervention: Device: Standard of Care with EASY DSS
• Active Comparator: 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.

  Intervention: Other: Standard of Care without EASY DSS

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2020): 311
• Original Estimated Enrollment (submitted: August 20, 2017): 484
• Actual Study Completion Date: December 19, 2019
• Actual Primary Completion Date: December 12, 2019 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03258268
• Other Study ID Numbers: EASY-1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Läkarexpressen AB
• Study Sponsor: Läkarexpressen AB

Collaborators

• Region Skane
• Lund University
• Region Halland
• Västra Götalandsregionen

Investigators

• Principal Investigator: Damon Tojjar, MD; Lund University

• PRS Account: Läkarexpressen AB
• Verification Date: September 2020