Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Dietetic support (Behavioral)
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.
干预措施: Dietetic support (Behavioral)
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.
干预措施: Continuous glucose monitoring (Device)
结局指标
主要结局
HbA1c
时间窗: baseline, 6 months
Glycated haemoglobin concentration
次要结局
- HbA1c(3 months)
- 24 h assessment of glycaemia(baseline, 6 months)
- Fasting blood glucose(baseline, 3 months, 6 months)
- hs-CRP(baseline, 3 months, 6 months)
研究者
Evelyn Parr
Principal Investigator
Australian Catholic University