search
Back to results

Easy Diabetes Treatment Study 1 (EASY-1)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Standard of Care with EASY DSS
Standard of Care without EASY DSS
Sponsored by
Läkarexpressen AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Region Halland
  • Region Skåne
  • Västra Götalandsregionen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard of Care with DSS

Standard of Care without DSS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1c
Change from baseline HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2017
Last Updated
September 30, 2020
Sponsor
Läkarexpressen AB
Collaborators
Region Skane, Lund University, Region Halland, Västra Götalandsregionen
search

1. Study Identification

Unique Protocol Identification Number
NCT03258268
Brief Title
Easy Diabetes Treatment Study 1
Acronym
EASY-1
Official Title
A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Läkarexpressen AB
Collaborators
Region Skane, Lund University, Region Halland, Västra Götalandsregionen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized controlled trial
Masking
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.
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care with DSS
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care without DSS
Arm Type
Active Comparator
Arm Description
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
Device
Intervention Name(s)
Standard of Care with EASY DSS
Intervention Description
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
Other
Intervention Name(s)
Standard of Care without EASY DSS
Intervention Description
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 Outcome Measure Information:
Title
HbA1c
Description
Change from baseline HbA1c
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Fasting plasma glucose
Description
Change from baseline in fasting plasma glucose (FPG)
Time Frame
26 weeks
Title
Achieving treatment target
Description
Meeting treatment target of HbA1c < 7% (53 mmol/mol)
Time Frame
26 weeks
Title
Hypoglycemia
Description
Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damon Tojjar, MD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Halland
City
Halland
Country
Sweden
Facility Name
Region Skåne
City
Skåne
Country
Sweden
Facility Name
Västra Götalandsregionen
City
Västra Götaland
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Easy Diabetes Treatment Study 1

We'll reach out to this number within 24 hrs