None listed
Conditions
Brief summary
This project is designed to assess the feasibility and acceptability of using Continuous Glucose Monitor Sensors (CGMS) in people with diabetes attending the Tweed Valley Hospital High Risk Foot Clinic Diabetes Multidisciplinary Team (TVH HRFC Diabetes MDT). The clinic comprises of the lead podiatrist, a diabetes educator and diabetes dietitian as well as consulting medical specialists including vascular, infectious disease, orthopeadic and endocrinology. The MDT clinic manages people with diabetes and active diabetes related foot ulcers, understanding the importance of achieving adequate glucose control to assist in the management of these wounds. The study protocol proposes a randomised feasibility trial where the intervention in the study is the use of CGMS within a cohort in the TVH HRFC Diabetes MDT and comparing this to another group that does not receive the CGMS. Both groups will otherwise receive the usual care that is provided within this clinic. We hypothesize that the use of the CGMS will assist to improve glucose control, improve diet quality, reduce diabetes distress and ultimately improve wound healing. Further, we believe that participants using the sensor will find the process acceptable and beneficial to their care.
Interventions
The intervention is the use of Continuous Glucose Monitoring System (CGMS) during an occasion of service in a Diabetes Multidisciplinary Team (MDT) High Risk Foot Clinic (HRFC). The intervention is delivered by the diabetes educator within the MDT clinic and supported by the wider MDT. The clinic is conducted face to face and last for approx. 1 hour and usually consists of fortnightly consults over approximately 3 months (depending on the course of wound healing). Participants are provided with
The intervention is the use of Continuous Glucose Monitoring System (CGMS) during an occasion of service in a Diabetes Multidisciplinary Team (MDT) High Risk Foot Clinic (HRFC). The intervention is delivered by the diabetes educator within the MDT clinic and supported by the wider MDT. The clinic is conducted face to face and last for approx. 1 hour and usually consists of fortnightly consults over approximately 3 months (depending on the course of wound healing). Participants are provided with appointment times and reminders are provided through the health service booking system. For those in the intervention group, the CGMS will be applied at the initial appointment with the Diabetes MDT HRFC and will last for up to 15 days. A second sensor will be applied a fortnight later in a subsequent Diabetes MDT HRFC appointment. The CGMS is in addition to the usual care that is provided with this clinic.
Sponsors
Northern NSW LHD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult (18 years old or greater) patients of the HRFS diagnosed with type 1 or type 2 diabetes and with an active foot wound, including re-ulceration.
Exclusion criteria
People who are treated for palliative wound management. People already using CGMS to monitor their glucose levels.
Outcome results
None listed