Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Change in Hemoglobin A1c From Baseline to 3 Months
研究概览
简要总结
Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration >6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly over secure text messaging with participants and their parents. Following active remote monitoring, the participants will wear a non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 13-18
- •Diagnosis of type 1 diabetes for at least six months.
- •Both sexes and all ethnicities included.
- •Subject and at least one parent able to communicate in English.
- •Poorly controlled T1D as evidenced by a >30% annual risk of developing DKA in the following year OR Hemoglobin A1c ≥ 12%
- •Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
- •Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
- •Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
- •Willing to participate in secure text messaging with study personnel.
- •Female participants must have a negative pregnancy test.
排除标准
- •Type 2 diabetes, secondary diabetes or CF related diabetes.
- •Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
- •Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
- •Patients with uncontrolled hypothyroidism (TSH >20) or uncontrolled hyperthyroidism will be excluded from the study. Patients with out of range values may be retested after medication dose adjustment.
- •Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A >15 at time of enrollment is an exclusion criterion.
- •Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
- •Pregnancy, planned pregnancy or breast feeding
- •CGM adhesive allergy
- •Skin condition that makes CGM placement contraindicated.
- •Sickle cell disease or hemoglobinopathy
- •Red blood cell transfusion within 3 months prior to study enrollment
结局指标
主要结局
Change in Hemoglobin A1c From Baseline to 3 Months
时间窗: 3 months
Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging)
次要结局
- Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.(3 months)
研究者
Abha Choudhary
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center