Can the use continuous glucose monitors in a Diabetes Multidisciplinary Team High Risk Foot Clinic improve patient related outcomes - A feasibility study.

INTERVENTION: 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. CONDITION: Diabetes;Diabetic Foot Ulcer; ; Diabetes ; Diabetic Foot Ulcer Metabolic and Endocrine ‐ Diabetes Skin ‐ Other skin conditions PRIMARY OUTCOME: glycated haemoglobin (HbA1c)[Point of Care HbA1c machine. At admission to the Diabetes MDT High Risk Foot Clinic and three months later.] SECONDARY OUTCOME: Adherence to study protocol.[Recording of number and type of protocol deviations. Data will be collected via review of the electronic medical record and study‐specific reporting forms. Throughout the course of the study. Approximately 15 months ‐ 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.] Adverse effects[Any amputation related to the participants diabetes related foot ulcer ; i) Major amputation – Any resection through or proximal (above) to the ankle ; ii) Minor amputation ‐ Any resection through or distal (below) to the ankle. ; Assessed via electronic medical records. Assessed throughout admission to HRFC. Approximate length of admission in the Diabetes MDT HRFC is 3‐months] CGMS Compliance ‐ % of data availability over the sensor life[CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group.] Emotional distress related to diabetes management.[The Problem Areas In Diabetes (PAID) validated questionnaire. Baseline, On discharge from service ‐ exact timepoint dependent on depending on the course of wound healing. Approximate length of admission in the Diabetes MDT HRFC is 3‐months] Food and nutrient composition of participants usual dietary intake. [Australian Eating Survey for Adults ‐ Food Frequency Survey Baseline, On discharge from service ‐ exact timepoint dependent on depending on the course of wound healing. Approximate length of admission in the Diabetes MDT HRFC is 3‐months.] Glucose Management Indicator (GMI). An estimated HbA1c level based on CGMS data over a set period [CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group] Glucose variability. Percent coefficient of variation (%CV); A target of less than 36% is set as being define as having adequate glucose variability.[CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group] Health service utilisation ‐ admission to hospital related to participants diabetic foot ulcer.[Number of admissions by participants to an acute hospital related to their diabetic foot ulcer. Data will be collected from review of electronic medical records. Throughout the course of the study. Approximately 15 months ‐ 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.] Health service utilisation related to participants diabetic foot ulcer ‐ Emergency Department (ED) presentations.[Number of presentations by participants to an ED related to participants diabetic foot ulcer. Data will be collected from review of electronic medical records. Throughout the course of the study. Approximately 15 months ‐ 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.] Loss to follow‐up [Number of participants not completing all study elements within each arm. This data will be collected. This data will be collected via review of electronic medical records and study‐specific reporting forms. Throughout the course of the 12 month study.] Percentage of missing data.[Overall assessment by percentage of individual data pieces that are missing for each participant. Data will be collected via review of the electronic medical record and study‐specific reporting forms. Throughout the course of the study. Approximately 15 months ‐ 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.] Percentage randomised.[Percentage of participants who consent to partake in the study who are randomised to either the control or intervention group. The source of this data will be an audit of the RedCap screening and randomisation data form. Throughout the course of the study recruitment ‐ 12 months.] Rates of recruitment[Percentage of people identified as eligible to partake in the study who consent to taking part in the study. The source of this data will be an audit of the RedCap screening and randomisation data form. Throughout the course of the study recruitment ‐ 12 months.] Rates of screening.[Percentage of eligible participants who undergo appropriate screening for the study. The source of this data will be an audit of the RedCap screening and randomisation data form. Throughout the course of the study recruitment ‐ 12 months.] Risk of lower limb amputation[The Wound, Ischemia, foot Infection (WIfI) Classification Baseline and at each wound assessment by Podiatrist until wound healing or ] Time Above Target (Cat 1: 10.1 ‐ 13.9 mmol/L & Cat 2: >13.9mmol/L)[CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group] Time Below Target (Cat: 1: 3.0‐3.8mmol/L & Cat2: <3.0mmol/L).[CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group.] Time in Target (3.9‐10.0 mmol/L) [CGMS data accessed via the Tweed Byron Services portal on the cloud based FreeStyle diabetes management service ‐ LibreView. At 2 and 4 weeks post commencement of CCGMS in intervention group] Wound Assessments ‐ Time to heal[Time to Heal ‐ Length of time from initial assessment to healing. Time to heal is defined as the number of days from baseline until complete epithelialisation of the target wound without drainage or need for dressings, confirmed at two consecutive visits at least 2 weeks apart. This assessment is completed by the treating podiatrist. ; Time To Heal ‐ Baseline to full healing. ; ] 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.