The goal of the study is to compare whether an integrated model of care between Foot Wound and Diabetes Clinic with use of remote glucose monitoring technology (Intervention Arm), as compared with usual care without the use of remote glucose monitoring technology (Control Arm), will result in 1) improved glycemic control, 2) improved ulcer and wound healing, 3) improved patient reported outcomes (PROs), 4) reduced long-term healthcare resource utilization, and 5) improved adherence to anti-glycemic therapy for patients with DFUWI and poor glycemic control over the course of a 6-month intervention period.
This is a two-arm non-randomized convenient pilot trial to assess impact of an active glycemic management model through remote glucose monitoring technology amongst patients with DFUWI and poor glycemic control at the Parkland Diabetes Foot \& Wound clinic. The plan is to implement a remote glucose monitoring technology to facilitate improved glycemic management and control. A cellular enabled glucose meter that will upload blood glucose measurements to a cloud server accessible by providers who can remotely review glycemic trends and remotely provide patients with proactive recommendations for treatment adjustments will be used. Patients receiving services in the integrated care model (same day visits in the Foot Wound and Diabetes Clinics at Parkland) will be eligible for inclusion in the intervention arm which includes proactive glucose monitoring guided by remote glucose monitoring technology. Patients receiving usual care services (non-integrated care model clinic days where Foot Wound and Diabetes Clinic visits are on separate days) will be eligible for inclusion in the control arm. The expectation is that patients in the intervention arm will experience greater improvements in glycemic control, compared to the usual care model. The hypothesis is that improved glycemic control in these patients will result in faster healing of diabetic foot wound, infections or ulcers. The effectiveness of the technologically facilitated integrated model of care will be evaluated compared to the usual care using metrics for diabetic foot ulcers and wound healing, glycemic control, patient reported outcomes, health resource utilization and medication adherence after 6 months of intervention. The Telcare 2.0 BGM for remote self-blood glucose monitoring(FDA Cleared) will be used.
Study Type
OBSERVATIONAL
Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.
Parkland Health and Hospital System
Dallas, Texas, United States
Change in HbA1c
Mean change in HbA1c from baseline to end of treatment
Time frame: 6 months
Glycemic control
Proportion of patients with lower A1C and insulin use
Time frame: 6 months
Foot ulcer and/or wound healing
Complete wound healing as defined by University of Texas Health System
Time frame: 6 months
Patient reported satisfaction with diabetes treatment
Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) \[Scale range 0-48\]; lower scores represent worse outcomes
Time frame: 6 months
Patient reported health status
Self-reported outcome assessment questionnaires using the 5 level EQ-5D health status measure (EQ-5D-5L) \[Scale range 5-25\]; higher scores represent worse outcome
Time frame: 6 months
Proportion of patients with emergency department visits
Proportion of patients with emergency department visits following enrollment
Time frame: 6 months
Proportion of days covered score
Proportion of days covered score represents an indirect measure of medication adherence and represents the proportion of days medication was dispensed (numerator) over the total potential days the medication should have been dispensed (denominator)
Time frame: 6 months
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Proportion of patients with hospitalization
Proportion of patients with hospitalization following enrollment
Time frame: 6 months
Frequency of invasive procedures
Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection
Time frame: 6 months
Number of outpatient visits
Total number of outpatient visits for general or specialized care (including virtual visits) during trial
Time frame: 6 months
Number of casts and boots used for treatment
Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection
Time frame: 6 months
Overall hospital incurred patient-specific cost
Cost (in US $) of overall patient care for Parkland during study enrollment
Time frame: 6 months
Cost of glycemic management during study
• Cost of glycemic management during trial, including cost of encounters (including telephone and virtual visits), testing supplies, drug costs, technology costs specifically related to glycemic management
Time frame: 6 months