Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

NCT06375460

Diabetes Mellitus, Type 2 Lifestyle Hyperglycemia +1 more

NOT_YET_RECRUITING NA

Telemedicine for Reach, Education, Access, and Treatment for Diabetes Self-Management Education and Support

NCT06626347

Type 1 Diabetes (T1D)

ACTIVE_NOT_RECRUITING NA

Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

NCT01920256

Type 2 Diabetes

COMPLETED NA

Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies

NCT06229236

Diabetes Mellitus, Type 1

COMPLETED NA

Diabetes Learning in Virtual Environments Just in Time for Community Reentry

NCT05286892

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

One group of patients, upon randomization, will immediately begin participation in a remote, pharmacist-driven clinic that will initiate and titrate medications according to a standardized medical algorithm. The comparator group 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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medication & Education-First

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.

Group Type ACTIVE_COMPARATOR

SGLT2 inhibitor, GLP-1 RA

Intervention Type DRUG

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

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.

Group Type EXPERIMENTAL

SGLT2 inhibitor, GLP-1 RA

Intervention Type DRUG

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

Education-First

Intervention Type BEHAVIORAL

For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SGLT2 inhibitor, GLP-1 RA

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

Intervention Type DRUG

Education-First

For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

27 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes