Continuous Glucose Measurement, Dietary Modification, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Continual Glucose Monitoring, Type 2 Diabetes, Non-insulin dependant Diabetes, Dietitian Support, Health Behaviours
Brief summary
A parallel, single-blinded, randomised clinical trial conducted remotely across Australia from the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with type 2 diabetes, by researchers from Australian Catholic University, University of Adelaide, University of Queensland, University of Wollongong, Monash University, Monash Partners, Deakin University, La Trobe University and Melbourne University.
Detailed description
In a parallel groups design, a total of 156 individuals will be recruited. After baseline pathology (HbA1c), blinded (Libre Pro iQ) continuous glucose monitoring (CGM) data and questionnaires (via REDCap) have been collected, participants will be randomised into one of two groups (DIET, dietetic support only; CGMD, CGM plus dietetic support). All participants will receive four (4) dietetic consults via telehealth at weeks 2, 6, 10 and 16, the content of which will be related to the randomised condition. Measurements will be repeated at 3 and 6 months from baseline to assess the changes in primary and secondary outcomes.
Interventions
BEHAVIORALDietetic support
Dietary advice will be provided by Accredited Practicing Dietitians (APDs) in line with evidence-based guidelines, specifically the T2DM best-practice guidelines plus Australian Dietary Guidelines (i.e. Australian Guide to Healthy Eating) to improve diet quality, and strategies to promote adherence.
DEVICEContinuous glucose monitoring
Abbott FreeStyle Libre 2+ CGM sensors will be used to provide feedback on interstitial glucose concentrations over 15 day periods per sensor. Nine sensors will be provided for the 6-month period, for 3 months of continuous use and 3 months of intermittent (2 weeks on - 2 weeks off) use.
Sponsors
Australian Catholic University
Abbott Diabetes Care
University of Adelaide
The University of Queensland
Monash University
University of Melbourne
Deakin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18+ years * Reside anywhere in Australia and have a postal address * Confirmed T2D diagnosis by a GP/endocrinologist * Current HbA1c of ≥7.0% * Have a smartphone and able to independently use it
Exclusion criteria
* Under the age of 18 years * Use of insulin therapy (within the last three months) or medications which interfere with blood glucose levels (i.e. steroids) * Use of CGM within the last six months * Eating Disorder Examination Questionnaire (EDE-Q) global score \>2.8 OR global score \> or equal to 1.52, with sum of Q14-18 \> or equal to 4 * Currently having ongoing consultations with an APD or have had a consult with an APD (within last three months) * Not weight stable (\>5 kg change over last three months) * Severe hypoglycaemic event (i.e. requiring assistance) within last six months * Change of antihyperglcyaemic medications within last three months * Women who are pregnant or breastfeeding (within 24 weeks) * History of psychotic disorder, or current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder) * History of blood disorders (including but, not limited to, anemia and thalassemia) that impact the primary outcome (HbA1c)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | baseline, 6 months | Glycated haemoglobin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 months | Glycated haemoglobin concentration |
| 24 h assessment of glycaemia | baseline, 6 months | 24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV) |
Countries
Australia
Outcome results
None listed