Ben J. Wheeler, New Zealand
University of Otago Women's and Children's HealthPresenter of 3 Presentations
CUTANEOUS ADVERSE EVENTS IN A RANDOMISED CONTROL TRIAL OF FLASH GLUCOSE MONITORING AMONG ADOLESCENTS WITH TYPE 1 DIABETES
- Brooke L L. Marsters, New Zealand
- Sara Boucher, New Zealand
- Barbara C. Galland, New Zealand
- Esko Wiltshire, New Zealand
- Martin De bock, New Zealand
- Andrew R. Gray, New Zealand
- Paul A. Tomlinson, New Zealand
- Jenny Rayns, New Zealand
- Karen E. Mackenzie, New Zealand
- Huan Chan, New Zealand
- Ben J. Wheeler, New Zealand
Abstract
Background and Aims
There is limited literature regarding flash glucose monitoring (FGM) associated cutaneous adverse events (AE). This study aimed to evaluate participant reported cutaneous AEs and sensor use associated with the Freestyle Libre FGM compared to usual care with SMBG as part of a six-month multisite randomised controlled trial (RCT) among adolescents with T1D.
Methods
Patients aged 13-20 years with type 1 diabetes ( [pre-enrolment mean HbA1c ≥75mmol/mol (≥9%)] were randomised to intervention (FGM and usual care), or control (self-monitoring blood glucose and usual care). Participants self-reported AEs every 14 days for six months. Reports were analysed to determine frequency, type, and severity and cause, as well as premature sensor loss.
Results
64 participants were recruited, 33 randomised to FGM and 31 controls. In total, 80 cutaneous AEs were reported, 40 in each group, however the proportion of participants experiencing AEs was greater in the FGM group compared to control (58% and 23% respectively, p = 0.004). FGM participants most frequently reported erythema (50%) while controls most commonly reported skin hardening (60%). For both groups the majority of AEs were rated as mild. One participant ceased using FGM due to reoccurring cutaneous AEs. 27/33 (82%) FGM participants experienced at least one premature sensor loss, largely unrelated to an AE.
Conclusions
Frequency of cutaneous AEs were similar for FGM compared to SMBG, with most AEs rated as mild. For FGM, the majority of users continued use despite AEs. Awareness of cutaneous complications and efforts to mitigate them may reduce cutaneous AEs associated with FGM use.
EXPLORING PARENTAL EXPERIENCES OF USING MIAOMIAO FOR CONTINUOUS GLUCOSE MONITORING AMONG CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES - A QUALITATIVE STUDY
Abstract
Background and Aims
MiaoMiao is a Bluetooth™ transmitter, which when paired with a smart phone/device, converts the Abbott FreeStyle Libre flash glucose monitoring system into a do-it-yourself (DIY) continuous glucose monitor (CGM). Families are adopting MiaoMiao, but little is known about parent and child experiences with this add-on technology. We aimed to explore experiences of families using MiaoMiao CGM including challenges faced and their advice to others who may choose to use the technology.
Methods
Between May and July 2019, we conducted twelve semi-structured interviews (in person or via videoconference) with parents of children (aged <17 years) with type 1 diabetes using MiaoMiao CGM. Interviews were audio recorded; professionally transcribed and key themes were identified through thematic analysis.
Results
Overall, parents used MiaoMiao CGM to proactively manage their child’s blood glucose. In all participants, this led to a perceived decrease in frequency of hypoglycaemia. Participants reported that the visibility and easy access to blood glucose readings, glucose trends, and customised alarms on parent’s phones decreased their disease burden and improved their sleep quality. Common barriers to using MiaoMiao CGM included difficulty of the setting up process, connectivity issues, and lack of support from medical teams.
Conclusions
This study highlights the potential feasibility of using a DIY CGM system like MiaoMiao CGM, which could be an empowering and cost-effective tool for enabling remote monitoring of blood glucose in real time.
MANAGING DIABETES IN A ‘FLASH’: EFFECT OF 6 MONTHS’ FLASH GLUCOSE MONITORING IN ADOLESCENTS WITH HIGH-RISK GLYCAEMIC CONTROL – A RANDOMISED CONTROLLED TRIAL
Abstract
Background and Aims
To investigate whether flash glucose monitoring (FGM) significantly improves glycaemic control compared with traditional self-monitored capillary blood glucose (SMBG) in adolescents and young adults with high risk glycaemic control and type 1 diabetes (T1D).
Methods
This 6-month randomized, industry independent, two-arm, parallel, controlled, multi-center open-label study included adolescents with type 1 diabetes, and glycated haemoglobin (HbA1c) ≥ 75mmol/mol (9%). Patients were randomly assigned to either an intervention group (FGM; FreeStyle Libre, Abbott) or a control group (SMBG), in a 1:1 ratio. The primary outcome was change in HbA1c from baseline to 6 months.
Results
In an intent-to-treat analysis of 64 participants (mean ± SD age 16.6 ± 2.1; 33 male), 33 participants were randomized to FGM and 31 participants to control. Baseline HbA1c was 94.0 ± 18.0 mmol/mol (10.8 ± 3.8%) and 98.8 ± 17.8 (11.2 ±3.8 %) in the FGM and SMBG groups, respectively. At 6 months, HbA1c decreased in both groups (86.1 ± 16.5 [10.0 ± 3.7%] and 93.2 ± 15.9 [10.7 ± 3.6%] in the FGM and SMBG groups, respectively) with no evidence of differences in changes between groups (adjusted mean 2.1 mmol/mol greater improvement for FGM, 95% CI -5.4 to 9.6, p=0.576). Total glucose testing frequency increased in the FGM group, performing 2.8 more glucose checks/day compared to SMBG (p<0.001).
Conclusions
Despite demonstrating an increase in glucose testing behaviour, this study provides no evidence that FGM alone improves glycemic outcomes over SMBG in adolescents and young adults with high risk glycemic control.