Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
研究概览
简要总结
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.
详细描述
At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that is "blinded" for 14-days so that we can gather baseline data about blood sugar levels.
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study. After wearing the blinded sensor, the study team will place participants in one of two groups:
One group (intervention group) will be shown how to use the sensors along with the FreeStyle Libre App, and the other group (control group) will continue with their standard diabetes care without using the CGM system. Participants will be "randomized" into one of the study groups described below. Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data.
Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study.
Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer. Participants will be asked to perform 2 checks a day, fasting and 2 hours post dinner as is standard practice.
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
- None
盲法说明
N/A both study team and participants will know the randomization assignment as to which group they are in.
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8- 20 years at the time of consent.
- •Clinical diagnosis of type 2 diabetes.
- •Duration of type 2 diabetes at least 4 weeks.
- •HbA1C ≥ 6.5% .
- •Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
- •No use of CGM 90 days before screening visit.
- •English or Spanish speakers.
- •Willing to abide by recommendations and study procedures.
- •Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
- •Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- •Plan for undergoing bariatric surgery during the study period.
- •Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
- •Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
- •Pregnancy or lactation.
- •Currently undergoing cancer treatment or systemic treatment with steroids.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
结局指标
主要结局
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
时间窗: Measured at 6 months
The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability
Feasibility of CGM use measured with Feasibility of Intervention Measure.
时间窗: Measured at 6 months
The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use
Ability to use CGM
时间窗: Measured at 6 months
Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application.
Appropriateness of CGM use measured with Intervention Appropriateness Measure
时间窗: Measured at 6 months
The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use
次要结局
- Time below low glucose range(Baseline (0) to 6 months)
- Dietary measures(Baseline (0) to 6 months)
- Time in target glucose range(Baseline (0) to 6 months)
- Time above high glucose range(Baseline (0) to 6 months)
- Time below glucose range(Baseline (0) to 6 months)
- Frequency of taking diabetes medications(Baseline (0) to 6 months)
- Glycemic change(Baseline (0) to 6 months)
- Change in BMI(Baseline (0) to 6 months)
- Physical activity measures(Baseline (0) to 6 months)
- Co-efficient of variation of glucose(Baseline (0) to 6 months)
- Quality of Life score on survey(Baseline (0) to 6 months)
- Time above glucose range(Baseline (0) to 6 months)
- Glucose management indicator(Baseline (0) to 6 months)
- Problem Areas in Diabetes(Baseline (0) to 6 months)
- Starting or stopping medications(Baseline (0) to 6 months)
- Titration of insulin dosing by provider(Baseline (0) to 6 months)