Phase 4
Completed N=200
Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Source: ClinicalTrials.gov NCT06046560 ↗Enrolled (actual)
200
Serious AEs
1.9%
Results posted
Oct 2024
Primary outcomePrimary: Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time — 81; 47 Participants
◆ Published Evidence
Established
25citations · ~13 / year
Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial.
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.
Linked Publications (2)
-
Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial.
-
Safety of a remote disease management program to improve sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists prescribing in type 2 diabetes with elevated cardiovascular or kidney risk.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time |
81; 47 | — |
| SECONDARY Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months |
62; 7 | — |
| SECONDARY Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months |
81; 47 | — |
| SECONDARY Change in Short-form Patient Activation Measure (PAM) |
0.3; 0.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06046560) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.