Summary: This publication is a study protocol, not a results paper. It describes the planned D-REM pragmatic, two-group, parallel-arm randomized trial in which 150 adults with diabetes and a history of level 3 hypoglycemia across five Minnesota counties are to be randomized to community paramedic home visits over roughly one month versus usual care. No efficacy or safety outcomes are reported, because none have yet been collected.
PICO Summary
| Element | Detail |
|---|---|
| Population | Planned n=150 adults (aged 18 years or older) with diabetes and a history of level 3 (severe) hypoglycemia, recruited from an integrated health system and the primary ambulance service across five counties in southeast Minnesota, USA. Design: pragmatic, two-group, parallel-arm randomized clinical trial (protocol only; NCT04874532). |
| Intervention | Community paramedic-led D-REM program: home visits over approximately one month delivering individually tailored diabetes self-management education, plus written diabetes education and resource materials (intervention arm; planned approx. 75 participants). |
| Comparison | Usual care with written diabetes education and resource materials only, no community paramedic visits (control arm; planned approx. 75 participants). |
| Outcome | No results reported. Planned outcomes, assessed at baseline, 1 month, and 4 months, are change in diabetes self-management, hypoglycemia, hyperglycemia, hemoglobin A1c, diabetes distress, and health-related quality of life. A nested qualitative component plans interviews with 16 intervention participants and 16 decliners. No effect sizes, confidence intervals, p-values, or ARR/NNT are available, as this is a protocol describing a trial that has not yet reported data. |
Expert Commentary
The verdict on effectiveness is that there is no verdict yet, and that point must be stated plainly because the original framing of this post implied a proven benefit that does not exist. What has been published is a protocol, so nothing has been measured, and claims that community paramedics improved diabetes management or reduced severe hypoglycemia are not supported by these data. The rationale is reasonable. Severe hypoglycemia is a marker of fragmented care and unmet self-management needs, and a brief home-based, paramedic-delivered education program is a plausible way to reach people who are difficult to engage through clinic visits alone. The pragmatic, randomized, two-arm design is appropriate, and pre-registration (NCT04874532) is reassuring. The most important limitation, beyond the absence of results, is that the planned sample of 150 is modest and the intervention is open-label by necessity, so once outcomes appear they should be read with attention to whether self-reported self-management measures moved more than the harder endpoints of hemoglobin A1c and objectively captured hypoglycemia. Can I use this with my patients? Not yet, because no outcome data have been reported; this is a study to watch rather than a practice to adopt. When the results are published, the figures of interest will be between-arm differences in severe hypoglycemia and A1c with confidence intervals. Until then, the honest position is to await the trial readout before changing how severe hypoglycemia is managed.
References
Bhagra S, Ducharme-Smith AL, Juntunen MB, Liedl CP, Golembiewski EH, Sundt WJ, et al. Diabetes rescue, engagement, and management (D-REM) for hypoglycemia: clinical trial protocol of a community paramedic program to improve diabetes management among adults with severe hypoglycemia. PLoS One. 2025;20(6):e0322177. doi:10.1371/journal.pone.0322177
