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| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
| University of Adelaide | OTHER |
| The University of Queensland | OTHER |
| Monash University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietetic support only | Active Comparator | 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. |
|
| CGM plus dietetic support | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietetic support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycated haemoglobin concentration | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycated haemoglobin concentration | 3 months |
| 24 h assessment of glycaemia | 24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV) |
| Measure | Description | Time Frame |
|---|---|---|
| CGM application and use | number of days of CGM use and interaction with viewing CGM data (via LibreLink); CGMD group ony | From 0 to 26 weeks, per 2 week period of sensor use |
| Per protocol analysis | Primary analysis of the primary outcome (0-6 months HbA1c) is going to be intention to treat. Therefore, secondary analysis of all other variables will be a per-protocol (PP) analysis. Inclusion in PP analysis will be defined by: 1. Attendance at ≥3 dietetic consults, within ±10 days of the designated 2-, 6-, 10- and 16-week time points. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Australian Catholic University | Melbourne | Victoria | 3065 | Australia |
The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publicly available, as it contains information that could compromise research participant consent.
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Reasonable requests of data for academic use will be considered. Requests can be made to the corresponding author of the publication. Data will not be made publicly available as it contains information that could compromise research participant consent.
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| OTHER |
| University of Melbourne | OTHER |
| Deakin University | OTHER |
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| Continuous glucose monitoring | Device | 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. |
|
| baseline, 6 months |
| 6 months |
| Dietary intake | energy and macronutrient composition calculated from food records | baseline, 3 months, 6 months |
| Fasting blood glucose | fasting blood glucose concentrations | baseline, 3 months, 6 months |
| Adherence | measures of adherence assessed by self-report (questionnaire) | baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks, 20 weeks, 26 weeks |
| hs-CRP | fasting high sensitive C-Peptide concentrations | baseline, 3 months, 6 months |
| Fasting cholesterol | Fasting cholesterol concentrations (total, HDL and LDL) | baseline, 3 months, 6 months |
| Fasting lipid concentration | fasting triglyceride concentrations | baseline, 3 months, 6 months |
| Medication effect score (MES) | Medication effect score for antihyperglycemic medications | baseline, 6 months |
| Participant experience | Qualitative semi-structured interviews | 6 months |
| Physical activity | Self-reported questionnaire (International Physical Activity Questionnaire (IPAQ) - Long Form) | baseline, 3 months, 6 months |
| Sleep quality and quantity | Self-reported questionnaire (Pittsburgh Sleep Quality Index (PSQI)) | baseline, 3 months, 6 months |
| Eating behaviours | Self-reported questionnaire (Eating Disorders Examination Questionnaire (EDEQ)) | baseline, 3 months, 6 months |
| Health literacy | self-reported questionnaire (Health Literacy Questionnaire (HLQ)) | baseline, 3 months, 6 months |
| Dietary quality | Assessed using the Healthy Eating Index For Australian adults (HEIFA) | baseline, 3 months, 6 months |
| Diabetes self-management | Self-reported questionnaire (Diabetes Self-Management Questionnaire (DSMQ-R)) | baseline, 3 months, 6 months |
| Diabetes distress | Self-reported questionnaire (Type 2 Diabetes Distress Assessment Scale (T2DDAS)) | baseline, 3 months, 6 months |
| Overall well-being | Self-reported questionnaire (WHO-5) | baseline, 3 months, 6 months |
| Diabetes-specific well-being | Self-reported questionnaire (DAWN Impact of Diabetes Profile (DIDP-7)) | baseline, 3 months, 6 months |
| Treatment satisfaction | self-reported questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQs (status) and DTSQc (change))) | baseline, 3 months, 6 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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