Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin - the Association With Metabolic Control of Diabetes and Markers of Early Vascular Changes
The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin. Additionally, the study aims to assess the association between metabolic control of diabetes and markers of early cardiovascular disease, taking into account the impact of CGM use.
研究概览
详细说明
Pharmacological treatment of type 2 diabetes (T2DM) has advanced significantly in recent years. However, despite increasing availability of new medications, a great proportion of patients do not achieve treatment goals, which leads to an increased risk of chronic complications. Continuous glucose monitoring (CGM) systems have become standard of care in persons with diabetes treated with insulin, although they might also be a useful tool in guiding behaviour and dietary choices in patients treated with non-insulin medications. However, the data on their potential benefits in people with T2DM not using insulin are scarce. Therefore, the study aims to investigate the influence of CGM use on metabolic control and quality of life in this group of patients.
The study subjects will be randomly assigned to one of two groups: using continuous glucose monitoring systems or performing self-monitoring of blood glucose with a glucose meter. The intervention time will be 12 weeks, with control visits every 4 weeks. A post-intervention follow-up visit to assess whether the achieved results are maintained will be performed at 3 months after completing the intervention.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Anna Krentowska, MD, PhD
- 电话号码：+48858317761
- 邮箱：anna.krentowska@umb.edu.pl
学习地点
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Bialystok、波兰、15-276
- 招聘中
- Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases
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接触：
- Anna Krentowska, MD, PhD
- 电话号码：+48858317761
- 邮箱：anna.krentowska@umb.edu.pl
-
首席研究员：
- Anna Krentowska, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 65 years (both inclusive)
- Type 2 diabetes diagnosed at least 6 months prior to entering the study
- Body mass index ≥25 kg/m2
- Diabetes treated with oral medications and/or GLP-1 receptor agonists and/or tirzepatide
- No modifications of diabetes treatment in the previous 3 months
- HbA1c between 7.5% and 10% (both inclusive)
- Oral and written informed consent for participation
Exclusion Criteria:
- Type 1 diabetes, gestational diabetes, other specific types of diabetes
- HbA1c >10.0%
- Treatment with insulin
- Previous use of any continuous glucose monitoring system
- GFR <30 ml/min
- Acute infections, acute diabetes complications and/or unplanned hospitalisations in the previous month
- Use of steroids or immunosuppressive medications in the previous 3 months
- Chemotherapy, radiotherapy, immune therapy in the previous 3 months
- Pregnancy and/or breastfeeding
- Skin lesions or dermatological conditions preventing proper sensor insertion
- Cognitive impairment and/or other conditions preventing proper use of continuous glucose monitoring system
- Lack of consent for the use of continuous glucose monitoring system
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Continuous glucose monitoring
Dexcom One+ continuous glucose monitoring system |
Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks. |
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其他：Self-monitoring of blood glucose
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Participants will be randomized to continue self-monitoring of blood glucose with a glucose meter as per usual practice, with control visits every four weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in time in range
大体时间：Week 12
|
Observed change in time in range (70-180 mg/dl) from baseline to week 12 in the group using CGM system compared to the group using SMBG. |
Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in HbA1c
大体时间：Week 12
|
Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12. |
Week 12
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Change in TITR
大体时间：Week 12
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Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12. |
Week 12
|
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Change in TAR
大体时间：Week 12
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Observed change in time above range (TAR; >180 mg/dl) from baseline to week 12. |
Week 12
|
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Change in TBR
大体时间：Week 12
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Observed change in time below range (TBR; <70 mg/dl) from baseline to week 12. |
Week 12
|
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Change in CV
大体时间：Week 12
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Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12. |
Week 12
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Change in body weight (kg)
大体时间：Week 12
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Observed change in body weight from baseline to week 12. |
Week 12
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Change in markers of early vascular disease
大体时间：Week 12
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Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from baseline to week 12. |
Week 12
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Change in diabetes distress: DDS
大体时间：Week 12
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Observed change in diabetes distress measured with DDS questionnaire from baseline to week 12. DDS is a 17-item questionnaire assessing diabetes distress over the previous month. Scores <2 points indicates no/little distress, 2-2.9 points - moderate distress, and ≥3 points - high distress. |
Week 12
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Change in PHQ-9
大体时间：Week 12
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Observed change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 12. PHQ-9 is a 9-item questionnaire for screening, diagnosing, monitoring and measuring the severity of depression. Total score: 0-27 points; higher scores reflect greater severity of depressive symptoms. |
Week 12
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Change in quality of life: WHOQOL-BREF questionnaire
大体时间：Week 12
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Observed change in abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire from baseline to week 12. Total score: 0-100 points; higher scores reflect higher quality of life. |
Week 12
|
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Change in sleep quality: PSQI
大体时间：Week 12
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Observed change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI) from baseline to week 12. Total score: 0-21 points; a score greater than 5 indicates significant sleep difficulties. |
Week 12
|
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Change in TIR after completing the intervention
大体时间：Week 24
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Observed change in time in range (TIR; 70-180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
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Change in HbA1c after completing the intervention
大体时间：Week 24
|
Observed change in the percentage of glycated haemoglobin (HbA1c) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
|
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Change in TITR after completing the intervention
大体时间：Week 24
|
Observed change in time in tight range (TITR; 70-140 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
|
|
Change in TAR after completing the intervention
大体时间：Week 24
|
Observed change in time above range (TAR; >180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
|
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Change in TBR after completing the intervention
大体时间：Week 24
|
Observed change in time below range (TBR; <70 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
|
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Change in CV after completing the intervention
大体时间：Week 24
|
Observed change in glycaemic variability assessed with coefficient of variation (CV) from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
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Change in markers of early vascular disease after completing the intervention
大体时间：Week 24
|
Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from week 12 (end of intervention) to week 24 (post-intervention follow-up). |
Week 24
|
合作者和调查者
合作者
调查人员
- 首席研究员：Anna Krentowska, MD, PhD、Medical University of Bialystok
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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