Easy Diabetes Treatment Study 1

NCT03258268 | Completed DMC

• 1 other identifier: EASY-1
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change from baseline HbA1c

  26 weeks

Secondary Outcomes (3)

• Fasting plasma glucose

  26 weeks

• Achieving treatment target

  26 weeks

• Hypoglycemia

  26 weeks

Study Arms (2)

Standard of Care with DSS

EXPERIMENTAL

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

Standard of Care without DSS

ACTIVE COMPARATOR

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

Interventions

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 with DSS

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.

Standard of Care without DSS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Läkarexpressen AB: lead
• Region Skane: collaborator
• Lund University: collaborator
• Region Halland: collaborator
• Västra Götalandsregionen: collaborator

Study Sites (3)

Region Halland

Hålland, Sweden

Location

Region Skåne

Skåne, Sweden

Location

Västra Götalandsregionen

Västra Götaland, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Damon Tojjar, MD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized controlled trial

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 23, 2017
• Study Start: August 7, 2017
• Primary Completion: December 12, 2019
• Study Completion: December 19, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)