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Easy Diabetes Treatment Study 1 (EASY-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258268
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Region Skane
Lund University
Region Halland
Västra Götalandsregionen
Information provided by (Responsible Party):
Läkarexpressen AB

Tracking Information
First Submitted Date  ICMJE August 20, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE August 7, 2017
Actual Primary Completion Date December 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2017)
HbA1c [ Time Frame: 26 weeks ]
Change from baseline HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Easy Diabetes Treatment Study 1
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2020)
311
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2017)
484
Actual Study Completion Date  ICMJE December 19, 2019
Actual Primary Completion Date December 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03258268
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Läkarexpressen AB
Study Sponsor  ICMJE Läkarexpressen AB
Collaborators  ICMJE
  • Region Skane
  • Lund University
  • Region Halland
  • Västra Götalandsregionen
Investigators  ICMJE
Principal Investigator: Damon Tojjar, MD Lund University
PRS Account Läkarexpressen AB
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP