Continuous Glucose Monitoring (CGM) in Prediabetes: A Mixed-Methods Study Exploring Behavioural Impact, Patient Experiences and Provider Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Dietary intake
研究概览
简要总结
Part 1 and 2 of study (For Patient Participants) The purpose of this study is to examine if the wearing of a medical device called a continuous glucose monitor (CGM) can guide adults with prediabetes modify their behaviors and manage their health, compared to traditional health coaching. Prediabetes means the study participants have a higher-than-normal blood sugar level which is not high enough to be considered type 2 diabetes yet but will put them at risk of developing it. CGM measures glucose levels without the participants having to prick fingers and involves wearing a small sensor on the back of the arm day and night which allows viewing of glucose levels on the mobile phone with a painless 1 second scan.
This is the first time the investigators are trying to do research using CGM for adults with prediabetes. the study team want to learn how practical it is to do such a study. The study will explore if wearing of a CGM sensor makes a difference in terms of health outcomes compared to regular health coaching. It also aims to understand the users' experience with the CGM system.
This study targets to recruit 76 participants from Pasir Ris Polyclinic.
Part 1 of the study uses a research method called a randomized controlled trial. Participants who consent to join will be allocated to one of two groups based on chance. Half of the participants will receive the CGM sensor in addition to health coaching. This is called the intervention group. The other half of the participants will receive health coaching alone. This is called the control group. Participants in both groups will continue regular follow-up with their own primary care physicians.
There will be 3 study touchpoints, which will mainly be at Pasir Ris Polyclinic.
- Baseline visit:
- Receive health coaching that will take 20-30 minutes.
- Complete questionnaires about socio-demographic details, diet and physical activity which will take 20-30 minutes.
- Measure weight, body mass index (BMI), and waist circumference.
- Past medical history and medications will be retrieved from the electronic medical records.
- If the participants are in the intervention group, the study team will assist them to apply the Abbott Freestyle Libre continuous glucose monitoring (CGM) sensor and link it to their smartphone. The study team will also set up the LibreLink app and Libreview account.
- 1-month touchpoint
- Complete follow up questionnaires to assess any changes in the diet and physical activity.
- This touchpoint may be conducted either face-to-face or via a phone call.
- 6-month touchpoint
- Complete final questionnaires about the lifestyle.
- Measure weight, BMI and waist circumference again
- Uninstall the LibreLink app and Libreview account.
Part 2 of the study is an in-depth interview to understand the experiences of the participants using the Abbott Freestyle Libre CGM System. This part of the study will be conducted either during the 3rd study touchpoint or on another day (within 9 months from start of intervention). The interview will last 60 minutes and will be audio-recorded. Questions asked will be regarding the general experience using the CGM, any difficulties with following the study instructions and suggestions to improve the study.
Part 3 of study for Healthcare Providers Participants (HCP):
The purpose of this study is to assess the effects of CGM on adults with prediabetes and to explore the facilitators and barriers of using CGM in prediabetes management from both patients and healthcare providers. The study aims to understand the perspectives of primary care providers on the potential benefits, challenges, and feasibility of integrating CGM into prediabetes management. The findings will help pave the way for broader integration of CGM technology into public health programs targeting specific populations at high risk of diabetes to improve health outcomes.
If the participants agree to participate, they will be invited to fill in a data collection form on the demographics, qualifications and clinical experience. This will take 20-30 minutes. The participants will be interviewed either individually or in a group with other of their colleagues from the same polyclinic. During the interview, the researcher will ask questions pertaining to their experiences with prediabetes management, knowledge of CGM and their views of the potential challenges and opportunities in the utilization of CGM by prediabetic adults. The interviews will be audio recorded. participation in the study will last approximately 60 minutes.
详细描述
BACKGROUND The World Health Organization (WHO) has identified diabetes as a priority non-communicable disease and launched initiatives to promote its prevention and management. Type-2 diabetes mellitus (T2DM) account for 90% of all global diabetes cases. Many countries have implemented national screening programs for early interventions and mitigate the associated complications. Such screening programs result in identifying people with pre-diabetes, a dysglycemic state in which the individuals are at increased risks of developing T2DM. Pre-diabetes include those with impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) or both IGT and IFG. At least 35% of individuals with pre-diabetes will progress to T2DM within eight years without lifestyle changes. Individuals with prediabetes also have an increased risk of developing microvascular and macrovascular complications, even before progressing to frank T2DM.
The global prevalence of IGT and IFG in 2021 was 9.1% (464 million) and 5.8% ((298 million) respectively and is expected to rise to 638 million in 2045. The prevalence of prediabetes is highest in developed countries. Singapore is no exception; 14% of its adult population being identified with prediabetes.
Pre-diabetes opens a window for early intervention to de-escalate the progression to T2DM. Lifestyle interventions such as diet or exercise for adults with prediabetes can effectively mitigate their dysglycemia. A meta-analysis on pooled results from eleven randomized controlled trials reported that individuals with prediabetes who underwent lifestyle interventions had 36% lower risk of progressing to T2DM, resulting in significant gains in their quality adjusted life-years. In the Diabetes Prevention Program, the incidence of T2DM was reduced by 34% with lifestyle modifications and 18% with metformin at the 10-year follow-up. However, the potential success of effective lifestyle modifications is diluted by difficulties in adherence to healthy behaviors.
Failure to control pre-diabetes is multi-factorial. At the individual level, people with pre-diabetes lack understanding of their glycemic state and are unaware of the dietary and lifestyle measures to prevent its deterioration. They have limited access to interventions in structured programs, and do not receive adequate follow-up care or support after their diagnosis, leading to inaction. At the system level, traditional diets high in refined carbohydrates and unhealthy cooking can be difficult to modify. Social gatherings and workplace environments may also discourage healthy behaviors. The rising prevalence of obesity, sedentary lifestyle and unhealthy diets have contributed to the increasing failure to control pre-diabetes. Harnessing medical technology to enhance self-efficacy in pre-diabetes management is an option to overcome these multi-faceted barriers.
Existing tools such as continuous glucose monitoring (CGM) has been shown to improve diabetes care by providing direct and timely feedback to patients with T1DM or T2DM on their meal-related glycemic fluctuations. It is preferred over traditional capillary blood glucose monitoring due to convenience, comfort and ease of use. CGM has been deployed in prediabetes in small-scale studies in the United States of America and Canada, which reported that its short-term use in adults increased their adherence to lifestyle interventions, such as reducing food portion sizes, choosing healthier food alternatives, and increasing physical activity levels. Subsequently, the Asia-Pacific Diabetes Care Advisory Board in 2021 has recommended individuals with prediabetes to leverage on CGM to gather constant feedback on their glycemic status and to motivate their behavioral change.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Participants
- •Inclusion Criteria:
- •Singaporean Citizen or Permanent Resident
- •Age 21 - 69 years old
- •Clinical diagnosis of prediabetes defined as a fasting glucose of 6.1-6.9 mmol/L and/or 2-hour glucose level of 7.8-11.0 mmol/L after an oral glucose tolerance test (Appropriate Care Guide, 2021)
- •a. Can be conservatively managed, or medically managed with metformin
- •Owns a mobile phone that can download the Singapore FreeStyle LibreLink App
- •Expressed willingness to use participate in the study, use the devices according to the study protocol during the study period, and to sign informed consent.
排除标准
- •Pregnant or planned pregnancy within the next six months
- •Physical limitation that prevents the patient from engaging in physical exercise
- •Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)
- •Not adequately proficient in English
- •Currently enrolled in another study or program that involves weight loss or dietary modifications, or novel therapeutic drug or device
- •Planned surgery in the next six months
- •Not able to use smartphone or the Singapore FreeStyle LibreLink App despite coaching
- •Any end-stage disease with life prognosis of < 2 years
- •Patients who are not willing or are not able to commit to the entire study program
- •Healthcare Providers (HCP) Participants HCPs from Pasir Ris Polyclinic who self-reported to have treated adults with prediabetes will be enrolled for the interviews.
研究组 & 干预措施
Intervention
Participants in the intervention arm will wear the Abbott Freestyle Libre system for 2 weeks, in addition to usual care.
干预措施: Continuous Glucose Monitoring (Device)
Control
结局指标
主要结局
Dietary intake
时间窗: 0 weeks, 2-6 weeks, 24-28 weeks
37-item Diet Screener (DS) The DS was designed and validated in a multi-ethnic population locally aged 18-79 years to assess intakes of selected food groups that could represent overall dietary patterns. The screener covers intakes of whole grains, soya protein, fruit, vegetables, oily fish and dairy fat and demonstrates reasonably good validity and reproducibility relative to the more accepted but longer 163-item Food Frequency Questionnaire. It is therefore easier to administer during the study with minimal participant burden.
Physical activity using International Physical Activity Questionnaire Short Form
时间窗: 0 weeks, 2-6 weeks, 24-28 weeks
a validated 7-item instrument that measures an individual's physical activity in the last 7 days; measures metabolic equivalent of task (MET)-minutes per week. Participants are asked to report the days and time they spent in the last 7 days in 4 categories: vigorous activity (heavy lifting, aerobics, fast bicycling), moderate activity (light lifting, moderate bicycling), walking, and sitting (watching TV, reading). The total physical activity was calculated as the sum of the vigorous, moderate, and walking categories in metabolic equivalent minutes per week (MET-min per week scores). Questions on sitting are related to sedentariness and are scored separately. MET minutes represent the amount of energy expended carrying out physical activity. One MET is what the participants expend when they rest. To get a continuous variable score it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher score, better outcome.
Body weight
时间窗: 0 week, 24-28 weeks
Weight in kilograms
Height
时间窗: 0 week, 24-28 weeks
Height in meters
Body Mass Index
时间窗: 0 week, 24-28 weeks
Weight and Height will be combined to report Body Mass Index in kg/m\^2
Waist circumference
时间窗: 0 week, 24-28 weeks
Waist circumference in centimeters: Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest with a measuring tape. The mean value of two waist circumference measurements is used. Both measurements are repeated if there is a difference of more than 1 cm.
次要结局
- Participant recruitment numbers(6 months recruitment period)
- Drop-out rate(18 months study duration)
- Adherence rate to the sensor(2-6 weeks)
- Exploring views on the facilitators and barriers of behavioral change with CGM(24-28 weeks, to allow up to 36 weeks)
- Views and experiences of using CGM with the Abbott Freestyle Libre system(24-28 weeks, to allow up to 36 weeks)
- Views and experiences on the study protocol(24-28 weeks, to allow up to 36 weeks)
- Experiences with managing adults with prediabetes(Baseline, up to 60 minutes)
- Knowledge and experience with CGM(Baseline, up to 60 minutes)
- Views on using CGM in adults with prediabetes(Baseline, up to 60 minutes)
- Facilitators and barriers to offering CGM as part of prediabetes management to their patients(Baseline, up to 60 minutes)