PROJECT SUMMARY/ABSTRACT
Severe hypoglycemia in the management of diabetes is associated with high morbidity, mortality, psychological
distress, and impaired quality of life (QoL). Preventing hypoglycemia is challenging as high risk patients,
including those who have already experienced severe hypoglycemia, are often not identified; risk factors for
hypoglycemia are broad, spanning clinical and non-clinical domains; and diabetes management is often not
altered despite a high risk profile. Recognizing, actively engaging, and providing comprehensive care to at-risk
patients to address hypoglycemia risk factors and enhance diabetes self-management skills may help reduce
the frequency/severity of hypoglycemic events, alleviate diabetes distress, and improve QoL.
Community paramedics (CPs) are trained in disease prevention, management, and wellness in addition to
emergency response. They are uniquely positioned to deliver comprehensive patient-centered care,
particularly to clinically and psychosocially complex patients. They can engage patients in their homes, identify
clinical and non-clinical needs, provide education, and engage medical and social support services. Our team
has demonstrated that CP interventions for patients with high prior healthcare utilization can reduce
emergency department (ED) visits and hospitalizations by 25% and 56%, respectively, over a 6-month period.
We hypothesize that comprehensive management by CPs after being treated for severe hypoglycemia will
improve diabetes self-management, prevent hypoglycemia, reduce diabetes distress, and improve QoL.
The overall objective of this application is to assess the feasibility, preliminary efficacy, and acceptability of
Diabetes-REM (Rescue, Engagement, and Management) to improve diabetes self-management among adults
in southeast Minnesota who had been treated for hypoglycemia by Mayo Clinic Ambulance. CPs will receive
formal training on diabetes and its management, which will be developed by the study team. Using a two-group
parallel design, 150 adults will be randomly assigned to 1 month of Diabetes-REM or usual care. Both groups
will receive education materials on hypoglycemia/diabetes and clinical/community resources. In Aim 1, we will
evaluate the feasibility and efficacy of Diabetes-REM in improving diabetes self-management (primary
outcome), with secondary outcomes of hypoglycemia, hyperglycemia, diabetes distress, and QoL, all assessed
at month 1 (end of intervention) and month 4 (for durability of effect). In Aim 2, we will qualitatively examine
patient perceptions of Diabetes-REM, focusing on specific Diabetes-REM components of that did, or did not,
meet their needs.
This work naturally builds on our robust preliminary data and Dr. McCoy’s ongoing evaluation of clinical and
sociodemographic hypoglycemia risk factors supported by a NIDDK K23 Award, and will provide preliminary
data for broader implementation and evaluation of Diabetes-REM in a R01-funded randomized controlled trial.
