Periodic Continuous Glucose Monitoring to Support a Person-centered Approach During Diabetes Consultations in Patients With Type 2 Diabetes- A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The aim of this randomised controlled trial is to investigate the effectiveness of periodic CGM (continuous glucose monitoring) to support a person-centered approach versus self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes on glucose control and patient reported outcomes.
详细描述
This is a 16-week prospective, multicenter, randomised, open-labelled, two-armed study in adults with type 2 diabetes conducted at primary care practices in Sweden.
Periodic CGM group- Intervention group:
The participants in the intervention group will be provided with FreeStyle Libre (Abbott Diabetes Care). Participants wear the sensor and check their glucose level for a period of 28 days (14 days X 2) during week 0-4 and week 10-13.Patient's measurement data from the FreeStyle Libre system 2 will be transferred to the OneTwo Analytics (DDA) analysis tool for an automated analysis and this Insight report will be presented to the participants at visit week 4 (digital) and at visit week 16 (clinical). The diabetes nurse and the patient reviews and discuss trends, patterns, and challenges to support the person's self-care management of their type 2 diabetes. This approach is intended to facilitate communication and patient participation and create the conditions for shared informed decisions and health planning.
Self-monitoring of blood glucose, SMBG and usual care - Control Group The participants in the control group perform SMBG testing as usual including fasting, pre- or post-prandial measurements. They also receive usual care which comprises consultation with physician diabetes specialist or diabetes nurse depending on individual health care needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Type 2 diabetes with a duration of > 6 months
- •HbA1c 45-70 mmol/mol
- •Have a smartphone
- •Experience of self-monitoring of blood glucose prior to the study start
排除标准
- •Prandial insulin
- •Pregnancy or planning pregnancy during the study
- •Breastfeeding
- •Renal disease with estimated glomerular filtration rate (eGFR) <45 mL/ min/1.73 m2
- •Active malignancy or under investigation for malignancy
- •Severe visual impairment
- •Severe skin allergy that inhibits the use of a continuous glucose monitoring device
- •Glucocorticoids (systemic)
- •Planned or currently using weight reduction medications, programs, or surgery
- •Cognitively or psychologically unable to participate and read instructions
- •Enrolled in other clinical trials
- •Eating disorders
结局指标
主要结局
HbA1c
时间窗: change at week 16
mmol/mol
次要结局
- Percentage of time spent in range (Glucose)(change first 28 days in the study compared with the last 28 days)
- Percentage time spent in hyperglycaemia(change first 28 days in the study compared with the last 28 days)
- Percentage time spent in hypoglycaemia(change first 28 days in the study compared with the last 28 days)
- Average glucose value(change first 28 days in the study compared with the last 28 days)
- Standard deviation for glucose value(change first 28 days in the study compared with the last 28 days)
- Percentage time in euglycemia, time in target(change first 28 days in the study compared with the last 28 days)
- Number of hyperglycemic episodes per day(change first 28 days in the study compared with the last 28 days)
- Number of hypoglycemic episodes per day(change first 28 days in the study compared with the last 28 days)
- Fasting glucose level(change first 28 days in the study compared with the last 28 days)
- Data availability in % of all time(change first 28 days in the study compared with the last 28 days)
- Prandial delta within 2 hours, post - pre-prandial values for breakfast, lunch and dinner.(change first 28 days in the study compared with the last 28 days)
- Postprandial peak during 2 hours for breakfast, lunch and dinner.(change first 28 days in the study compared with the last 28 days)
- Night-time insulin effect(change first 28 days in the study compared with the last 28 days)
- The Diabetes Treatment Satisfaction questionnaire(change at week 16)
- WHO-5 Well-Being Index(change at week 16)
- The Patient Preferences for Patient Participation (4Ps)(change at week 16)
研究者
Unn-Britt Johansson
Principal Investigator, Professor
Sophiahemmet University