None listed
Conditions
Brief summary
Group One: Freestyle Libre blood glucose sensors and consults using telehealth Group Two: Freestyle Libre PRO combined with Freestyle Optium Neo blood glucose finger prick monitoring and face to face study visits. Aim: To compare Flash Libre glucose monitoring paired with Telehealth consultations versus standard SMBG monitoring with face-to-face clinic visits in people with diabetes who are undergoing discharge from hospital. Hypothesis: That, in at least 60 people with type 1 and type 2 diabetes who are being discharged from Royal Prince Alfred Hospital (RPAH) on insulin treatment, those randomised to the Freestyle Libre (Flash) will have favourable effect on glucose levels (time in range (TIR), estimated HbA1c (eHbA1c), hypoglycaemia frequency and glucose variability) compared to the traditional finger prick BGL group over a seven week period after discharge.
Interventions
Group 1: Freestyle Libre glucose monitoring (inserted into the upper arm) paired with Telehealth consultations in people with diabetes who are undergoing discharge from an acute care hospital. Each participant will be shown how to connect to video conferencing while they are in hospital and sent the link to their personal email address for a trial connection prior to discharge. All participants will be provided with training by a Diabetes Educator on insertion of the Libre sensor. The Freestyle
Group 1: Freestyle Libre glucose monitoring (inserted into the upper arm) paired with Telehealth consultations in people with diabetes who are undergoing discharge from an acute care hospital. Each participant will be shown how to connect to video conferencing while they are in hospital and sent the link to their personal email address for a trial connection prior to discharge. All participants will be provided with training by a Diabetes Educator on insertion of the Libre sensor. The Freestyle Libre sensor will be worn for 2 weeks then changed to a new sensor. Participants will be asked to wear 2 sensors (for 1 month) during the study period. Participants will also be asked to scan the sensor prior to each main meal and before bed and record the BGLs in a diary. The glucose data will be downloaded at the end of each 2 week period. The intervention will be conducted under the guidance of a Senior Endocrinologist with over 20 years experience in diabetes management. Both study groups will have seven study visits over nine weeks at a teaching hospital providing tertiary level ambulatory diabetes care. Usual standard of care (outside of pandemic health directives) would be face to face visits. This study will provide information on the effectiveness of telehealth compared to standard care. Study visits for participants randomised to Telehealth Visit 1: Participants will be recruited prior to discharge from hospital. Visit 2: On the day of discharge, a glucometer and an appointment for randomisation will be provided. Visit 3: One week after discharge from hospital, participants be randomised at a face to face. If randomised to Freestyle Libre (Flash) and telehealth, participants will receive training on how to connect to videoconferencing for telehealth visits. Visit 4 to 6: On three occasions at week 2, 3 and 5 after discharge, participants will be asked to connect for the telehealth reviews via videoconferencing. They will not attend in-person face to face appointments during this time. Telehealth consult duration will be 30-40 minutes. The consult will consist of glucose data review for the previous week, hypoglycaemia review and medication changes made as clinically indicated. Glucose graphs will be reviewed to monitor for adherence to the scanning of the glucose sensor. Visit 7: Seven weeks after discharge, the participant will attend a face to face end of study visit for BGL review.
Sponsors
Sydney Local Health District
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
1. Either type 1 or type 2 diabetes. 2. Inpatients with glucose instability in hospital defined as: a. Glucose readings over 15.0mmol/L on at least two separate occasions, and/or b. A glucose reading under 4.0mmol/L on at least one occasion. 3. Require insulin therapy and follow-up at the RPAH Diabetes Centre RADS clinic after discharge. 4. Over 18 years of age. 5. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Those who cannot use the Flash technology after having received training. 2. Those not able or willing to use telehealth. 3. People with severe hypoglycaemia in the last 3 months. 4. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 5. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements. 6. Participants requiring X-ray, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high frequency electrical heat (diathermy) treatment during the study period.
Outcome results
None listed