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Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.

NAACTIVE_NOT_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Aged 18+ years
  2. Reside anywhere in Australia and have a postal address
  3. Confirmed T2D diagnosis by a GP/endocrinologist
  4. Current HbA1c of ≥7.0%
  5. Have a smartphone and able to independently use it

Exclusion criteria

  1. Under the age of 18 years
  2. Use of insulin therapy (within the last three months) or medications which interfere with blood glucose levels (i.e. steroids)
  3. Use of CGM within the last six months
  4. Eating Disorder Examination Questionnaire (EDE-Q) global score >2.8 OR global score >= 1.52, with sum of Q14-18 >= 4
  5. Currently having ongoing consultations with an APD or have had a consult with an APD (within last three months)
  6. Not weight stable (>5 kg change over last three months)
  7. Severe hypoglycaemic event (i.e. requiring assistance) within last six months
  8. Change of antihyperglcyaemic medications within last three months
  9. Women who are pregnant or breastfeeding (within 24 weeks)
  10. History of psychotic disorder, or current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder)
  11. History of blood disorders (including but, not limited to, anemia and thalassemia) that impact the primary outcome (HbA1c)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT06888687

Intervention or treatment

BEHAVIORAL: Dietetic support

DEVICE: Continuous glucose monitoring

Conditions

  • Type 2 Diabetes Mellitus (T2DM)
  • Continuous Glucose Measurement
  • Dietary Modification

  • Condition: Type 2 Diabetes Mellitus (T2DM), Continuous Glucose Measurement and more

  • BEHAVIORAL: Dietetic support and other drugs

  • Melbourne, Victoria, Australia

  • Sponsor: Australian Catholic University

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Research sites nearby

Closest Location:

Australian Catholic University

Select from list below to view details:

  • Australian Catholic University

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

ACU

Australian Catholic University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Dietetic support only
  • 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.
Behavioral: Dietetic support
    EXPERIMENTAL: CGM plus dietetic support
    • 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.
    Behavioral: Dietetic support, Device: Continuous glucose monitoring

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      HbA1cGlycated haemoglobin concentrationbaseline, 6 months

      Secondary Outcome

      MeasureDescriptionTime Frame
      HbA1cGlycated haemoglobin concentration3 months
      24 h assessment of glycaemia24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV)baseline, 6 months
      Fasting blood glucosefasting blood glucose concentrationsbaseline, 3 months, 6 months
      hs-CRPfasting high sensitive C-Peptide concentrationsbaseline, 3 months, 6 months
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.

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