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Completed

NCT Number: NCT03258268

Easy Diabetes Treatment Study 1

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Halland, Hålland, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard of Care with EASY DSS

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 EASY DSS

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.

Primary outcomes

  1. HbA1c

    Time frame: 26 weeks

    Change from baseline HbA1c

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 26 weeks

    Change from baseline in fasting plasma glucose (FPG)

  2. Achieving treatment target

    Time frame: 26 weeks

    Meeting treatment target of HbA1c < 7% (53 mmol/mol)

  3. Hypoglycemia

    Time frame: 26 weeks

    Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes

Sponsors and collaborators

Lead sponsor

Läkarexpressen AB

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: EASY-1

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2017
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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