CGMs for All: Studying the Impact of Expanding CGM Access
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Mean Illness Intrusiveness Ratings Scale score (IIRS)
研究概览
简要总结
This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.
详细描述
This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers.
This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life.
FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor glycemic control (A1c at least 8) on insulin who may be unable to afford CGM. Once consented, participants will have point-of-care A1c testing as well as pregnancy testing (if applicable); patient eligibility based on glycemic control criterion should be determined by this A1c. Participants will then complete the study questionnaires. Clinic staff will teach CGM sensor placement and determine whether a reader is required or if a compatible mobile device for intermittent scanning will be used. Blood Glucose (BG) readings are provided via online Libre portal.
At the 6-week follow-up visit, the provider will recommend adjustments to the participant's medication regimen based on their BG trends on CGM and their clinical judgment. Providers will ask participants to report any adverse events, safety issues, or trouble with the CGM system thus far experienced.
At the 12-week follow-up visit, participants will repeat completion of study questionnaires and undergo second A1c measurement. Further adjustment to medication regimen is permitted as provider sees fit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Diagnosed with type 2 diabetes mellitus
- •A1c greater than or equal to 8.0 within two weeks of the time of enrollment
- •On insulin for at least one year +/- other antihyperglycemics
- •Ability and willingness to wear CGM for 14-day periods throughout the trial period
- •Ability and willingness to comply with provider-directed adjustments to medication regimen
- •Inability to afford CGM sensors
- •A note on Vulnerable Populations: Many of FHCHC's patients are economically disadvantaged and of minority backgrounds; the clinic's patient base may be considered to constitute a vulnerable population. As such, recruitment and enrollment will be conducted within a vulnerable population. The nature of the study requires this, and the results are intended to directly benefit this population through the potential for improved glycemic control and quality of life.
排除标准
- •Insulin naïve
- •Diabetic ketoacidosis (DKA) in previous 6 months
- •End-Stage Renal Disease (ESRD)
- •Contraindications to CGM use
- •Active insurance plan that would provide enough of a subsidy for participant to feasibly purchase CGM sensors
- •Pregnancy
研究组 & 干预措施
Poorly Controlled Type 2 Diabetes- CGM
Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks.
干预措施: Continuous Glucose Monitor (CGM) (Device)
结局指标
主要结局
Mean Illness Intrusiveness Ratings Scale score (IIRS)
时间窗: Baseline, 12 weeks, 24 weeks
The IIRS is a useful, easy-to-apply tool that measures the degree of illness-induced disruptions in the 13 different aspects of life. Total score range from 13 (minimal intrusiveness) to 91 (extreme intrusiveness).
Mean Hemoglobin A1c concentration
时间窗: Baseline, 12 weeks, 24 weeks
Mean A1c concentration in mg/dL measured in blood samples
次要结局
- Mean Treatment Burden Questionnaire (TBQ) score(Baseline, 12 weeks, 24 weeks)
- Mean Diabetes Distress Scale score (DDS-17)(Baseline, 12 weeks, 24 weeks)
- Mean Summary of Diabetes Self-Care Activities (SDSCA) score(Baseline, 12 weeks, 24 weeks)
- Score on digital supplement to TBQ (TBQ+D)(Baseline, 12 weeks, 24 weeks)
- Quality of life analogue scale(Baseline, 12 weeks, 24 weeks)
- TBQ+D Cognitive Interview tool(Baseline, 12 weeks, 24 weeks)