Pilot of a CGM-Augmented Food Is Medicine Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in percent of Time in Range (TIR)
研究概览
简要总结
This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention ("intervention") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone ("comparator").
At the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.
详细描述
This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or food insecurity. The study will enroll adults with type 2 diabetes not using insulin/secretagogues or CGM to be randomized 1:1 to the CGM-augmented FIM intervention (intervention arm) or a standard FIM intervention (comparator arm) for 12 weeks. All participants (N=60) will wear blinded CGM for 10 to 14-days at baseline and at week 12, and complete two random 24-hour dietary recalls during each blinded CGM wear-time. Participants in the intervention arm will wear real-time CGM for the duration of the 12-week intervention and receive a series of structured counseling sessions with a registered dietician. Following the 12-week intervention, all participants will receive both FIM intervention and wear real-time CGM for a 4-week extension phase. FIM intervention will be provided in the form of electronic healthy food vouchers.
At the 12-week and 16-week timepoints, participants will provide outcome data including blinded CGM data, hemoglobin A1c, dietary intake, and other patient-reported outcomes and feedback on their experience using questionnaires. After study completion, a subset of sampled participants will be invited to complete a semi-structured interview regarding their experience with the study. Participants in the intervention group will be invited after the completion of the intervention (beginning week 13) and participants in the comparator group will be invited to interview after completion of the entire study (beginning week 17). The primary outcomes measuring study feasibility and acceptability will collect data related to CGM and FIM use, including overall retention and phase completion, CGM wear-time, use of food subsidy, completion of meal logs, and satisfaction for the intervention. The primary outcomes measuring efficacy will collect diabetes outcomes, glycemic management, and a suite of patient-reported outcomes. Quantitative and qualitative results will be used to improve the intervention prior to rollout of a subsequent multicenter, fully powered randomized trial.
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
- Single (Participant)
盲法说明
Participants in the intervention arm will be blinded during Week 0 (Baseline) and Week 12 of the Intervention Phase for a period of 10-14 days to outcome assessments from the CGM wear.
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
- •Able to complete study activities in English
- •Aged ≥18 years
- •Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes
- •Chart review will be conducted by the study team and a diagnosis of type 2 diabetes (E.11.xx) from either the problem list or a diagnosis linked to an encounter will be used as confirmation. Discrepancies in diagnosis codes will be resolved by review of provider notes within the past 3 years.
- •HbA1c > 8.0% in the last 12 months via point of care or venous measurement. If there are multiple values, the most recent one will be considered.
- •Receiving primary or specialty care within UNC Health as defined by at least one visit with a primary care provider or endocrine provider within the past year
- •Indication of a barrier to healthy eating consisting of report of food insecurity (defined as a score greater or equal to 1.0 on the 6-item USDA Food Security Survey Module (FSSM)) and/OR nutrition insecurity (defined as more often than 'Rarely' on the One-Item Gretchen Swanson Nutrition Screener, OR more often than 'Not Very Hard' on the Two-item Nutrition Security Screener (NSS))
- •Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS
- •No plans to move from the area for at least 4 months
- •Willing and able to provide written informed consent and participate in all study activities
排除标准
- •Type 1 or other diabetes
- •Use of insulin or secretagogues in the preceding 6 months
- •Use of CGM in the preceding 6 months
- •Inability to use CGM and related technology (e.g., the companion app), including lack of a smartphone that is compatible with Stelo (information on compatible phones available in Appendix 1) or known allergy to adhesive
- •Known psychosis or major psychiatric illness that prevents participation with study activities
- •Pregnancy or planned pregnancy in the next 4 months-glycemic targets are different for pregnant women compared to non-pregnant women with diabetes and our intervention is designed for non-pregnant glycemic targets
- •Participant in diabetes, nutrition, or weight research intervention in last 12 months
研究组 & 干预措施
Intervention
CGM-Augmented FIM
干预措施: CGM-Augmented FIM (Behavioral)
Comparator
FIM only
干预措施: FIM only (Behavioral)
结局指标
主要结局
Change in percent of Time in Range (TIR)
时间窗: Baseline at Week 0, Post-intervention at Week 12
When using the blinded continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point. Change in TIR will be calculated across time-points.
Change in percent of Time Below Range (TBR)
时间窗: Baseline at Week 0, Post-intervention at Week 12
When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (\<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TBR will be calculated across time-points.
Change in percent of Time Above Range (TAR)
时间窗: Baseline at Week 0, Post-intervention at Week 12
When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (\>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TAR will be calculated across time-points.
Glycemic variability
时间窗: Baseline at Week 0, Post-intervention at Week 12
When using the blinded continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV). Change in %CV will be calculated across time-points.
Change in Hemoglobin A1c (HbA1c)
时间窗: Baseline at Week 0, Post-intervention at Week 12
HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint.
Change in Healthy Eating Index (HEI) Score based on two 24-hour recalls
时间窗: Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16
Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Healthy Eating Index (HEI) scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating from a select list of healthy food categories. The scores range from 0 to 100. An ideal overall Healthy Eating Index score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).
Change in Mediterranean diet scores
时间窗: Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16
Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Mediterranean diet scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating a set amount of serving from a select list of healthy food categories. The scores range from 0 to 9. An ideal overall Mediterranean diet score of 9 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).
Change in Dietary Approaches to Stop Hypertension (DASH) Scores
时间窗: Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16
Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Dietary Approaches to Stop Hypertension (DASH) scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating a set amount of serving from a select list of healthy food categories. The scores range from 8 to 40. An ideal overall DASH score of 40 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).
次要结局
- Change in food security using the USDA Food Security Survey Module(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Change in the presence and/or degree of nutrition security from the Two-item Nutrition Security Screener (NSS)(Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16)
- Change in the summed nutrition barrier score from the Two-item Nutrition Security Screener (NSS)(Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16)
- Change in the One-Item Gretchen Swanson Nutrition Screener(Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16)
- Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Change in Sources of Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Source Scores(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Changes in the Benefits of Continuous Glucose Monitor (BenCGM)(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Changes in the Burdens of Continuous Glucose Monitor (BurCGM)(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Changes in the 10-item Dietary Screener Questionnaire (DSQ) with a lookback of 30 days.(Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16)
- Change in Physical Activity Levels(Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16)
- Change in Food Assistance enrollment (SNAP / WIC) in the last 30 days.(Baseline at Week 0, Post-intervention at Week 12)
- Changes in financial strain, from the American Academy of Family Physicians (AAFP) Social Needs Screening Tool(Baseline at Week 0, Post-intervention at Week 12)
- Change in General Health Status(Baseline at Week 0, Post-intervention at Week 12)
- Change in EuroQol 5 Dimension, 5 Level (EQ-5D-5L)(Baseline at Week 0, Post-intervention at Week 12)
- Change in overall health status in the EuroQol 5 Dimensions, 5 Level (EQ-5D-5L)(Baseline at Week 0, Post-intervention at Week 12)