Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

Inclusion Criteria:

1. Understanding of the study procedures and conditions of the protocol and agreementto participate in the study by providing consent prior to any study-specificprocedures.

2. Male or female patients 18 years or older.

3. Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to theScreening Visit.

4. History of healed diabetic foot ulcer(s), present for at least 2 weeks and healedwithin 2-24 months prior to screening.

5. Confirmation of presence of peripheral neuropathy with loss of protective sensation (documented in medical records or certain ICD-10 codes for care of patients withdiabetes and loss of protective sensation)

6. Patient has signed up for and provided or will provide consent to review of medicalrecords available via the Pluto platform.

7. Access to internet service at the site of device use or willing to use a 4G routerprovided by the Sponsor

8. Access to cell phone on which they can receive study communications

9. Has a healthcare provider who is confirmed to be their point of contact for footcare or injuries and this HCP uses an EHR that is compatible with Pluto

10. English speaking

Exclusion Criteria:

1. Patients with active foot ulcers or other open foot lesions

2. Weight, when fully clothed, of greater than 150 kg

3. Active Charcot arthropathy defined as the phase where the foot is undergoingcollapse

4. Active foot infection or gangrene

5. Any history of major or minor lower limb amputation of more than 3 toes. NOTE: thehallux toe must be present on both feet to be eligible

6. Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicatesadequate perfusion and qualifies for the study

7. End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renalreplacement therapy)

8. Known pregnancy at the time of enrollment.*

9. Any mental health disorder, psychiatric disorder, or alcohol or drug abuse historysuch that, in the opinion of the investigator, the patient is unreliable as a studyparticipant

10. Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days.

11. Unable to identify and/or return to a usual care provider for foot care for theduration of the study

12. Unable or unwilling to be enrolled in the Pluto unified medical records system

13. Other issue that, at the discretion of the PI, renders the participant ineligiblefor participation. This includes inability to use the BMS for at least 3 days perweek.

• Participants who become pregnant during the study will not be removed.Pregnancy will be noted in their mobile application profile and theirparticipation in the study will be closely monitored.