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Completed

NCT Number: NCT06046560

Diabetes Remote Intervention to improVe Use of Evidence-based Medications

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.

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Key information

Age range

27 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 27 - 79 years at the time of agreeing to participate in the program
  • Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
  • HbA1c 6.5-8.9%; AND
  • 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
  • Has seen a primary care provider within the Mass General Brigham network within the last year

Exclusion criteria

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

Treatment and study plan

SGLT2 inhibitor, GLP-1 RA

Drug

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

Education-First

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.

Primary outcomes

  1. Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time

    Time frame: 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 outcomes

  1. Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months

    Time frame: 2-months following enrollment

    Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months

  2. Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months

    Time frame: At 6-months following enrollment

    Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months

  3. Change in Short-form Patient Activation Measure (PAM)

    Time frame: 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)

Other outcomes

  1. Change in Body Weight (kg)

    Time frame: From 0-months (baseline) to 6-months following enrollment

    Change in body weight (kg)

  2. Change in Body Weight (%)

    Time frame: From 0-months (baseline) to 6-months following enrollment

    Change in body weight (%)

  3. Change in Laboratory Measured HbA1c

    Time frame: From 0-months (baseline) to 6-months following enrollment

    Change in laboratory measured HbA1c

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Acronym: DRIVE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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