FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia

Launched by DASMAN DIABETES INSTITUTE · Oct 30, 2019

Keywords

ClinConnect Summary

Study design:

Open-label, crossover, single center, randomized controlled trial of FreeStyle Libre with MiaoMiao Bluetooth transmitter adjunct with calibrations (FSL-M) compared to FreeStyle Libre alone (FSL-A) in people with T1DM.

Protocol summary:

Following informed written consent, subjects will be randomized to either FSL-M group using FSL with Miaomio and Tomato App premium version, or FSL-A with Libre Link app (stage 1). Subjects will spend 8 weeks in the assigned group followed by 2 weeks washout then subjects will switch over to the other group for further 8 weeks (stage 2).

Whi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. T1DM for 12 months or more
• • 2. Age \>21 years old
• • 3. Established user of FreeStyle Libre for ≥3 months
• • 4. HbA1C \<12% (108mmol/mol)
• • 5. Able to check glucose with finger prick several times a day
• Exclusion Criteria:
• • 1. Pregnancy or plans for pregnancy over the duration of the study
• • 2. Breast feeding
• • 3. Renal impairment with eGFR \<30ml/minute/1.73m2
• • 4. Significant anaemia (males Hb\<110g/L, females Hb \<100g/L)
• • 5. Active malignancy
• • 6. Significant vision impairment
• • 7. Any significant illness- decision will be made by the PI or Co-I
• • 8. Not able to attend study visits
• • 9. Not able or not willing to participate in all study components
• • 10. Not able or not willing to give written informed consent