Easy Diabetes Treatment Study 1

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Standard of Care without EASY DSS; Device: Standard of Care with EASY DSS

• Registration Number: NCT03258268
• Lead Sponsor: Läkarexpressen AB

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 available

Study Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-08-20
• Study First Posted: 2017-08-23
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care without DSS	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.
Standard of Care with DSS	Standard of Care with EASY 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.

Primary Outcome Measures

Name	Time	Method
HbA1c	26 weeks	Change from baseline HbA1c

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Region Skåne; 🇸🇪 Skåne, Sweden

Västra Götalandsregionen; 🇸🇪 Västra Götaland, Sweden

Region Halland; 🇸🇪 Halland, Sweden