Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Phase 4

Completed

• Conditions: Diabetes; Cardiovascular Diseases
• Interventions: Drug: SGLT2 inhibitor, GLP-1 RA; Behavioral: Education-First

• Registration Number: NCT06046560
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.

Detailed Description

A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.

Study Timeline

• Study Start: 2021-03-22
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Results First Submitted: 2024-08-20
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged 27 - 79 years at the time of agreeing to participate in the program
2. Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
3. HbA1c 6.5-8.9%; AND
4. At elevated cardiovascular and/or renal risk defined as any diagnosed ASCVD, estimated ASCVD risk >10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (LDL-c above 160 mg/dL or 4.1 mmol/L, non-HDL-C above 190 mg/dL or 4.9 mmol/L, triglycerides above 175 mg/dL,) hypertension (2 systolic blood pressure values above 130 mmHg and/or 2 diastolic blood pressure values above 90 mmHg within 12 months,) or BMI above 30
5. Has seen a primary care provider within the Mass General Brigham network within the last year

Exclusion Criteria

1. Type 1 diabetes
2. Currently or previously prescribed an SGLT2i or GLP1-RA
3. Taking any short-acting insulin
4. History of diabetic ketoacidosis
5. History of hypoglycemia requiring hospitalization
6. Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose <70 mg/dL
7. eGFR below 15 ml/min/m2
8. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR
9. Life expectancy less than 1 year or utilizing palliative care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Education-First	SGLT2 inhibitor, GLP-1 RA	Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
Medication & Education-First	SGLT2 inhibitor, GLP-1 RA	Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.
Education-First	Education-First	Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time	Any time between 0-months (baseline) to 6-months following enrollment	Number of patients with prescriptions of SGLT2i or GLP1-RA at any time

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months	2-months following enrollment	Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months	At 6-months following enrollment	Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months
Change in Short-form Patient Activation Measure (PAM)	From 0-months (baseline) to 6-months following enrollment	Change in Short-form Patient Activation Measure (PAM); The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).; 0.0 - 1.0 (Disengaged \& Overwhelmed); 1.1 - 2.0 (Becoming Aware But Still Struggling); 2.1 - 3.0 (Taking Action \& Gaining Control); 3.1 - 4.0 (Maintaining Behaviors \& Pushing Further)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States