None listed
Conditions
Brief summary
The aim of this research study is to assess the feasibility of conducting a future randomised controlled trial using a continuous glucose monitor paired with an Australian mobile app that provides diet and lifestyle education, recommendations for reducing glucose spikes and support from a dietitian coach in a cohort of postmenopausal women at risk of type 2 diabetes (T2D). Empowering women with real-time glucose insights and personalised tools may enable sustainable lifestyle change. If feasible and acceptable, this model could support scalable, cost-effective interventions to reduce T2D risk in this vulnerable population.
Interventions
A feasibility clinical trial will be undertaken using a single arm, pre–post intervention design over a six month period. Twenty postmenopausal women at high risk of developing T2D as assessed by the validated Australian T2D Risk Assessment Tool (AUSDRISK) with current VMS who meet the inclusion and exclusion criteria will be recruited to the study.
Following recruitment, baseline anthropometric and cardiovascular health measures will be obtained. Participants will wear a continuous glucose moni
A feasibility clinical trial will be undertaken using a single arm, pre–post intervention design over a six month period. Twenty postmenopausal women at high risk of developing T2D as assessed by the validated Australian T2D Risk Assessment Tool (AUSDRISK) with current VMS who meet the inclusion and exclusion criteria will be recruited to the study. Following recruitment, baseline anthropometric and cardiovascular health measures will be obtained. Participants will wear a continuous glucose monitor (CGM; Sibionics) for 14 days and download a mobile app to log their food and drink consumption, physical activity, sleep onset, wake time and any VMS during this time. They will have access to the app for the entire six months of the study. The frequency of logs within the app will be recorded and analysed at the end of the study to assess participant adherence. The CGM will be used at four different time points across the six-month study – at baseline (CGM1), Month 2 (CGM2), Month 4 (CGM3) and Month 6 (CGM4). Participants will apply their baseline CGM (CGM1) and subsequently attend a pathology collection centre for a fasting blood draw and oral glucose tolerance test (OGTT). At the completion of CGM1, participants will be provided with access to the online diet and lifestyle education module within the app. The education module covers the following seven topics: glucose metabolism (27 articles), nutrition (15 articles), movement (9 articles), sleep (25 articles), stress (4 articles), ageing (3 articles) and menopause (17 articles). The self-paced module takes approximately 8.3 hours to complete and can be done in multiple sittings. Each article provides information that is written for a lay audience and can be read in five minutes or less. Embedded PubMed links allow readers to access the original published articles if they wish. The app records the completion of each article. Following completion of the education module, participants will be provided with their second (CGM2) and third (CGM3) at Months 2 and 4, respectively. Personalised recommendations to improve glucose metrics will be provided through AI and dietitian generated insights by integrating CGM responses and food logs. The dietician will also offer regular 15-minute synchronous online calls to provide advice tailored to individual dietary preferences and answer specific questions. At the end of CGM2, CGM3 and CGM4, an analytic report is created within the app that summarises an individual’s average 24 hour glucose levels and highlights areas of increased variability that may benefit from targeted diet and/or lifestyle changes. Anthropometric and cardiovascular health measures will be repeated before participants receive CGM4 at Month 6 and subsequently attend a pathology collection centre for a final fasting blood draw and OGTT. Feasibility of the intervention will be assessed within two weeks of CGM4 completion using validated post study questionnaires.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
41 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
Healthy postmenopausal women < 60 years of age living in South Australia following an omnivorous diet, AUSDRISK score greater than or equal to 12, experienced at least one/week of moderate or severe hot flashes or night sweats during the previous two weeks, naive to medications and supplements that affect vasomotor symptoms or metabolic status within the past three months, willingness to provide fasting blood draw and oral glucose tolerance test at baseline and 6-months, willingness to attend free self service health check (10 minutes) at baseline and 6-months, willingness to complete an online questionnaire at baseline, six-months and post-study, willingness to wear a continuous glucose monitor for 14 days, log the timing of food and drink consumption and vasomotor symptoms (repeated four times across the study), and a compatible smart phone.
Exclusion criteria
Surgically-induced menopause, early menopause (onset being less than or equal to 40 years of age), any current or historical diagnosed medical condition associated with metabolic health, current or historical smoker within the past five years, current or historical presence of inflammatory skin conditions, allergy to medical grade adhesives, history of bariatric surgery, current diagnosis of sleep disorders and/or shift work, current diagnosis of severe mental illness, and current or past diagnosis of disordered eating and/or greater than or equal to 15 score on the 12-item Short Form of the Eating Disorder Examination Questionnaire (EDE-QS).
Outcome results
None listed