Comparing diet support with and without glucose monitoring for type 2 diabetes
Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
This study tests whether adding continuous glucose monitoring to diet support helps people with type 2 diabetes manage their diet and blood sugar better than diet support alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Australian Catholic University Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06888687 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dietetic support with and without continuous glucose monitoring (CGM) on individuals with type 2 diabetes. A total of 156 participants will be randomly assigned to receive either dietetic support alone or dietetic support combined with CGM. The study will involve four telehealth dietetic consultations over 16 weeks, with assessments of blood glucose levels and dietary behaviors conducted at baseline, 3 months, and 6 months. The trial aims to determine the effectiveness of CGM in improving dietary management and glucose control in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of type 2 diabetes and an HbA1c level of 7.0% or higher.
Not a fit: Patients who are using insulin therapy or have a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance dietary management and glucose control for patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with continuous glucose monitoring in diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Melbourne, Victoria
- Australian Catholic University — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Evelyn B Parr, PhD
- Email: evelyn.parr@acu.edu.au
- Phone: +61 3 9230 8278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.