Glucose Risk Assessment in Employer Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Diabetes Status
研究概览
简要总结
This is an observational study to understand the glucose characteristics of the general population (normal glucose, pre-diabetes, and diabetes). Glucose risk will be measured with laboratory HbA1c and continuous glucose monitor (CGM) derived metrics. Physical activity will also be measured using a Fitbit activity tracker. The study will inform future programs that use CGM and activity tracking to identify people at risk for diabetes in the population.
详细描述
This is a prospective, single-center, observational study that will enroll a maximum of 550 subjects. All potential study subjects will be current or former employees or dependents eligible to enroll for Employer's group health plan and will demonstrate interest in response to recruitment materials placed in the near site clinic and/or the surrounding community. Participation interest will be demonstrated by calling the study number. Potential subjects will then undergo a screening call performed by study staff and, if still interested and likely eligible will be scheduled for Visit 1 and potential Visit 2. If a potential subject is not interested in continuing they will be given the option to anonymously complete a survey as to why they declined participation.
All potential subjects at Visit 1 will be required to provide written or electronic informed consent to participate. Once informed consent is obtained, study staff will confirm if there is a recent A1C available . If subject has a confirmed diagnosis of diabetes or pre-diabetes and an A1C result within the last 8-weeks or does not have diabetes or pre-diabetes and has an A1C within the last 6-months no A1C will be drawn. If the subject does not have a recent A1C a POC A1C will be taken at Visit 2. Study staff or subject will deploy the CGM system at Visit 1. Study staff will verify that the CGM is successfully blinded and subject has been trained on wearing CGM before subject completes Visit 1.
Subjects will be offered to wear an optional activity tracker and if chosen will also be required to download the activity tracker mobile application onto their personal smartphone. Subjects will then be trained on how to synchronize and charge their study activity tracker. To complete Visit 1 activities subjects will be asked to complete up to three surveys regarding their health status, reason for participation, diabetes risk, and if they decline to wear the activity tracker and why. Subjects upon leaving Visit 1 will confirm their return Visit 2 and remuneration will be processed at this time.
During the 10-day wear period subjects will have access to study staff in-person at the clinic and have Dexcom Technical Support available through a dedicated phone line Monday through Friday.
At Visit 2, study staff will assist subjects with removing the CGM and if wearing an activity tracker will also have it removed. Study staff will confirm the activity tracker has been synced with the subject's mobile application before deletion from the smartphone. Study staff will collect and record adverse events, serious adverse events, or unanticipated problems. Subjects will be asked to complete a user experience survey and have their mailing address confirmed for delivery of the final summary report and completion survey. A POC A1C will be obtained (unless a recent A1C and shared with subjects). Unless previously diagnosed with diabetes, subjects will be classified as normal glucose levels, prediabetes or diabetes based on their overall data. Subjects who are newly diagnosed with diabetes (POC A1C ≥ 6.5%) may be referred to their primary care physician. Remuneration will be processed at this time. Safety data will not be obtained for any subject after Visit 2 unless an ongoing AE is considered not resolved or ongoing and not stable.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current or former employee or dependent eligible to enroll in Employer's group health plan
- •Aged 18 years or older
- •Reads, speaks and understands English
- •Women of reproductive potential using one of the following highly effective modes of contraception: implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- •Willing to comply with all study procedures (including CGM wear) and be available for the duration of the 10 day study
- •If a subject consents to optional wear of an activity tracker, the subject must:
- •own a smartphone compatible with the Fitbit mobile application
- •be willing to download the application on their smartphone
- •be willing to use their assigned research account to sync data
- •be willing to charge and sync data as directed during the 10 day wear
排除标准
- •Currently using continuous glucose monitoring
- •An intellectual or learning disability, or unstable mental state, that could limit ability to obtain written or electronic informed consent and/or adhere to the study protocol
- •Medical condition that precludes participation, including the following contraindications to CGM wear:
- •Pregnant or planning to become pregnant
- •Critically ill
- •Planned medical interventions that are listed as contraindications to CGM wear, including
- •CT or MRI scan within 4 days of CGM insertion
- •Known skin issues and/or allergic reactions to components of the study product(s) (ex. medical-grade adhesives)
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- •Participation in another drug or device clinical trial concluding within 30 days of the screening visit.
结局指标
主要结局
Diabetes Status
时间窗: Clinic Visit 2 (about 10 days from study enrollment)
diabetes status will be determined by A1C record or clinically measured point-of-care A1C (no diabetes \<5.7%, pre-diabetes 5.7% to 6.4%, and diabetes \> or = to 6.5%).
次要结局
- CGM-derived Time Above Range (TAR)(10-days)
- Fitbit-derived sedentary time(10-days)
- CGM-derived Time Below Range (TBR)(10-days)
- Fitbit-derived daily steps(10-days)
- CGM-derived Time in Range (TIR)(10-days)
- Fitbit-derived light activity(10-days)
- Fitbit-derived moderate to vigorous activity(10-days)
- CGM-derived Glucose Variability(10-days)