Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes. (CARE-T2D)

Australian Catholic University (ACU)

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM); Dietary Modification; Continuous Glucose Measurement

Treatments: Device: Continuous glucose monitoring; Behavioral: Dietetic support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06888687

2024-3690HC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Dietetic support only

Active Comparator group

Description:

This group is designed to act as a comparator using 'standard care' in dietetics practice. Dietary advice provided to this participant group will be performed 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.

Treatment:

Behavioral: Dietetic support

CGM plus dietetic support

Experimental group

Description:

The CGM plus dietetic support group will be provided 'standard care' dietetic support alongside the use, and interpretation of, the CGM data collected to assist in the understanding of dietary modifications on glucose management. As per the DIET group, dietary advice provided to this participant group will be performed 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. The CGM data collected via LibreLink will be used by both the participant and the dietitian to inform dietary modifications.

Treatment:

Behavioral: Dietetic support

Device: Continuous glucose monitoring