CGM and DFU Healing Post-discharge

Summary

The purpose of this study is to look at the benefits of using a Continuous Glucose Monitoring (CGM) system compared with standard-of-care testing for patients with type 2 diabetes and diabetic foot ulcers (DFU) and how this will improve wound healing. The CGM system allows medical staff and patients with diabetes to monitor and make treatment decisions to improve glucose control, without the need for performing fingersticks. Hence, the use of CGM will decrease the painful and burdensome task of performing finger sticks several times per day and may prevent low blood glucose in patients with diabetes.

Eligibility

Inclusion Criteria:

* Adults aged 18 and over with type 2 diabetes admitted to the hospital with diabetic foot ulceration with or without infection (cellulitis or osteomyelitis)
* HbA1c \>= 8.0% at the time of enrollment
* Treatment of diabetic foot ulcer with medical management and/or a single toe amputation
* Patients with prior amputation at or below the ankle may be enrolled if they develop an ulceration in the foot that is not felt to be a surgical wound from prior amputation, defined as a healed surgical site for at least 6 weeks after the surgery before the onset of the new ulceration
* Wound, Ischemia, foot Infection (WIfI) score of 1-3
* Duration of DFU less than 1 year
* Able and willing to use continuous glucose monitoring technology independently or with the assistance of a close relative or caretaker

Exclusion Criteria:

* Age \< 18 years
* Homelessness or anticipated to have unstable housing after discharge
* A WIfI score of 4, denoting a very high risk for major amputation (above or below the knee) and very low odds of healing within 12 months
* Any amputation more extensive than just a single toe during index hospitalization
* Patients with type 1 diabetes
* Participants enrolled in another interventional clinical trial (including during the run-in period).
* Inability to participate in the informed consent process for any reason
* Female subjects who are pregnant or breastfeeding at the time of enrollment in the study
* Subjects planning to use CGM technology independent of the study following discharge
* Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG

Conditions3

Locations2 sites

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