跳至主要内容
临床试验/NCT06296550
NCT06296550招募中不适用

Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes

Scripps Whittier Diabetes Institute1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
HbA1c

研究概览

简要总结

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

详细描述

The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare & Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Diagnosed with type 2 diabetes
  • Are not currently using a CGM
  • Are not using insulin therapies
  • Speak English, Spanish or Arabic
  • Have A1c between 7.5% and 12.0% in last 90 days
  • Have a cellphone that can receive/send text messages and counts steps

排除标准

  • Are using insulin therapies
  • Are pregnant
  • Are currently using a CGM
  • Are currently participating in another diabetes-related study

研究组 & 干预措施

CGM Group

Experimental

Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months).

干预措施: Dulce Digital Text Messaging Intervention (Other)

CGM Group

Experimental

Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months).

干预措施: CGM Device (Other)

Usual Care Blood Glucose Monitoring Group

Other

Participants will use standard blood glucose monitoring devices that are covered by health insurance.

干预措施: Dulce Digital Text Messaging Intervention (Other)

结局指标

主要结局

HbA1c

时间窗: 6 months

Measures participants A1c using lab results provided from healthcare provider.

次要结局

  • CGM Metric Time Below Range(6 months)
  • CGM Metric Time in Range(6 months)
  • Summary of Diabetes Self Care Activities (SDSCA) Survey(6 months)
  • CGM Metric Time above Range(6 months)
  • Diabetes Distress Scale(6 months)

研究者

发起方
Scripps Whittier Diabetes Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验