Perspectives on Using a Nutrition-focused Approach When Initiating Continuous Glucose Monitoring in People With Type 2 Diabetes: a Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study
研究概览
简要总结
The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with type 2 diabetes (T2D) who received a nutrition-focused approach (NFA) when initiating continuous glucose monitor (CGM).
详细描述
The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with T2D who received the NFA when initiating CGM.
A single 30-minute semi-structured interview will be conducted in approximately 15 people who have completed participation in the A21-292 study (also called the My Diabetes Study).
The My Diabetes Study, is a randomized clinical trial to assess the impact of using a NFA or a self-directed approach during CGM initiation. The NFA was developed specifically for the randomized clinical trial study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Participant was randomized to the nutrition-focused approach arm of the My Diabetes study
- •Participant completed all required study visits in the My Diabetes study; this includes the baseline visit, the two intervention visits, and the study completion visit
- •Participant had at least 70% "Time CGM Active" on a 10-day Dexcom Clarity Report at study completion visit
- •Participant is willing to be recorded during the interview
排除标准
- •Participant was randomized to the self-directed approach study arm of the My Diabetes study
- •Participant is deemed unsuitable for participation due to any cause as determined by the Investigator
结局指标
主要结局
Describe CGM Data Use by 15 of the Participants During the UNITE/MyDiabetes Study
时间窗: Immediately following the 2-month study completion visit in the My Diabetes study.
30 minute interviews with each participant were transcribed and thematic coding was used to describe how participants in the My Diabetes Study used their CGM data when making food-related decisions after receiving a nutrition-focused approach during CGM initiation. Narrative summaries of the data were written up to describe the findings from all 15 participants. No objective outcome data is available to present in the outcome measure data table.
次要结局
- Describe the Overall Experience of 15 Participants Receiving a Nutrition-focused Approach During CGM Initiation During the UNITE/MyDiabetes Study(Immediately following the 2-month study completion visit in the My Diabetes study.)
研究者
Holly Willis
PhD, RDN, CDCES
HealthPartners Institute