NCT07529366招募中不适用
Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in hemoglobin A1c
研究概览
简要总结
The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are:
- Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group.
- Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18-70 years of age
- •prediabetes (HbA1c 5.7-6.4%)
- •compatible smartphone with the Dexcom Stelo sensor system
- •have not have worn a CGM in the last 6 months prior to enrollment
排除标准
- •any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes
- •problematic hypoglycemia in the prior 6 months [defined as recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL ) that persist despite multiple attempts to adjust medication(s) and/or modify the diabetes/treatment plan or a history of one level 3 hypoglycemic event (glucose <54mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia]
- •pregnant, or planning to become pregnant during the study time frame
- •currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition
- •a known allergy to medical grade adhesives,
- •use of any CGM device in the past 6 months
- •history of a diagnosed eating disorder
- •current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
- •subjects lacking capacity to provide informed consent
研究组 & 干预措施
No CGM Cohort (Retrospective Cohort)
A retrospective chart review will be performed on patients seen at the USF Health Department of Family Medicine between 1/1/2025-03/20/2026. Subjects in this group will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%). Subjects in this cohort will have not received CGM.
CGM Cohort (Intervention)
Subjects meeting inclusion criteria will include adults 18-70 years of age with prediabetes (HbA1c 5.7-6.4%) obtained within the six months preceding enrollment. Subjects must have a compatible smartphone with the Dexcom CGM sensor system. Subjects must not have worn a CGM in the last 6 months to be eligible.
干预措施: Dexcom Stelo CGM (Device)
结局指标
主要结局
Change in hemoglobin A1c
时间窗: Baseline to End of Study (12 weeks)
Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort
次要结局
- Time Below Range(Baseline to End of Week 4 (CGM wear period))
- Time in Range(Baseline to End of Week 4 (CGM wear period))
- Time in Euglycemic Range(Baseline to End of Week 4 (CGM wear period))
- Mean Sensor Glucose(Baseline to End of Week 4 (CGM wear period))
- Time Above Range(Baseline to End of Week 4 (CGM wear period))
- Glycemic Variability(Baseline to End of Week 4 (CGM wear period))
- Time in Range Increase 5%(Baseline to End of Week 4 (CGM wear period))
- Time in Range Increase 10%(Baseline to End of Week 4 (CGM wear period))
- Time in Euglycemic Range Increase 5%(Baseline to End of Week 4 (CGM wear period))
- Time in Euglycemic Range Increase 10%(Baseline to End of Week 4 (CGM wear period))
- >70% Time in Range(Baseline to End of Week 4 (CGM wear period))
- >70% Time in Euglycemic Range(Baseline to End of Week 4 (CGM wear period))
- Summary of Diabetes Self-Care Activities Measure (SDSCA)(Baseline to End of Study (12 weeks))
- Summary of Diabetes Self-Care Activities Measure (SDSCA)(Baseline to End of Week 4 (CGM wear period))
- 36-Item Short Form Health Survey (SF-36)(Baseline to End of Study (12 weeks))
- 36-Item Short Form Health Survey (SF-36)(Baseline to End of Week 4 (CGM wear period))
研究者
Kevin Cowart
Associate Professor
University of South Florida
研究点 (2)
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