Three-arm Pragmatic Randomized Study on the Effectiveness, Feasibility, Acceptability, and Cost of the Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 4
- 主要终点
- Impact of continuous and intermittent CGM use on blood glucose levels in comparison to standard of care in people living with type 1 diabetes
研究概览
简要总结
Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour.
In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs.
This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in South Africa.
详细描述
3 Study Design As this study is a PrCT the study aspects will be embedded in the normal clinical care delivery of diabetes care in the selected clinics (see section 3.2, Scientific Rational for Selection of Study Design). Introducing only 1 additional clinic visit and 1 additional qualitative visit for study related procedures. The primary outcome measure, HbA1c, will be assessed through the HbA1c testing that is already used in these clinics. It is important to note that the type of HbA1c test (i.e.: laboratory-based vs point-of-care) per participant must remain constant during the study, this is because of variability of performance between various HbA1c testing platforms.
3.1 General Design This is a three-arm pragmatic randomized control study. The expected duration of study participants involvement in the study is 15 months, this consists of 9 months of intervention with a follow up visit 6 months post the last interventional study visit. There will be 6 total study visits for all participants.
- Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
- Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.
- Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.
For all participants the first study visit will consist of:
- Enrolment including ICF,
- Baseline surveys including demographics, the Glucose Monitoring Satisfaction Survey (GMSS-T1D), HRQOL surveys, and diabetes distress score survey.
- Randomized assignment to study arm,
- Blood draw for HbA1c testing (if not already done in the previous 1 month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
- •People living with T1 diabetes with HbA1c current levels ≥10% within the last 3 months (and at least 2 HbA1c ≥10% within the last 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
- •Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
- •The child/adolescent that the person is a care giver to is enrolled in the study.
- •Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
- •Healthcare provider at the study sties engaged in diabetes care provision related to the study.
排除标准
- •Participants are excluded from the Study if any of the following exclusion criteria apply:
- •People living with T1 diabetes under 4 years old as this the minimum age for use of CGM as per the CGMs used in this study manufacturer instructions.
- •People diagnosed with T1 diabetes within the last 2 years.
- •People who have used a CGM in the last 6 months prior to enrollment.
- •People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months).
- •People living with Type 2 diabetes.
- •Known pregnancy at the time of study enrolment.
- •People who are not willing to agree to Freestyle Libre T&Cs
结局指标
主要结局
Impact of continuous and intermittent CGM use on blood glucose levels in comparison to standard of care in people living with type 1 diabetes
时间窗: 15 months
Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms
次要结局
- 3b. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable)(15 months)
- 1a. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.(15 months)
- 1b. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.(15 months)
- 1c.Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.(15 months)
- 1d. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.(15 months)
- 3a. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable)(15 months)
- 4a. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective.(15 months)
- 2. Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications.(15 months)
- 4b.Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective.(15 months)
- 4c. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective.(15 months)
- 5. Cost of continuous and intermittent CGM use from a user and provider perspective(15 months)