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临床试验/NCT03827902
NCT03827902撤回不适用

Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家开始时间: 2019年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in HbA1c

研究概览

简要总结

The goal of the study is to compare whether an integrated model of care between Foot Wound and Diabetes Clinic with use of remote glucose monitoring technology (Intervention Arm), as compared with usual care without the use of remote glucose monitoring technology (Control Arm), will result in 1) improved glycemic control, 2) improved ulcer and wound healing, 3) improved patient reported outcomes (PROs), 4) reduced long-term healthcare resource utilization, and 5) improved adherence to anti-glycemic therapy for patients with DFUWI and poor glycemic control over the course of a 6-month intervention period.

详细描述

This is a two-arm non-randomized convenient pilot trial to assess impact of an active glycemic management model through remote glucose monitoring technology amongst patients with DFUWI and poor glycemic control at the Parkland Diabetes Foot & Wound clinic. The plan is to implement a remote glucose monitoring technology to facilitate improved glycemic management and control. A cellular enabled glucose meter that will upload blood glucose measurements to a cloud server accessible by providers who can remotely review glycemic trends and remotely provide patients with proactive recommendations for treatment adjustments will be used. Patients receiving services in the integrated care model (same day visits in the Foot Wound and Diabetes Clinics at Parkland) will be eligible for inclusion in the intervention arm which includes proactive glucose monitoring guided by remote glucose monitoring technology. Patients receiving usual care services (non-integrated care model clinic days where Foot Wound and Diabetes Clinic visits are on separate days) will be eligible for inclusion in the control arm. The expectation is that patients in the intervention arm will experience greater improvements in glycemic control, compared to the usual care model. The hypothesis is that improved glycemic control in these patients will result in faster healing of diabetic foot wound, infections or ulcers. The effectiveness of the technologically facilitated integrated model of care will be evaluated compared to the usual care using metrics for diabetic foot ulcers and wound healing, glycemic control, patient reported outcomes, health resource utilization and medication adherence after 6 months of intervention. The Telcare 2.0 BGM for remote self-blood glucose monitoring(FDA Cleared) will be used.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Type 2 Diabetes
  • 18 years and older
  • A1C greater than or equal to 8.5% within the preceding 6 months
  • A1C greater than 8% on day of enrollment
  • Active diabetic foot ulcer or wound receiving treatment in the Foot Wound clinic at Parkland (ulcer that meets University of Texas Classification Grade 1 or 2 of any stage)

排除标准

  • Chronic osteomyelitis (even if completed active therapy)
  • Moderate/severe lower limb infection (per Infectious Diseases Society of America criteria)
  • Diabetic Foot Ulcer and Wound Infection on Charcot Foot
  • Any serious/unstable medical condition that interferes with treatment assignment
  • Ankle Brachial Index less than 0.7 or toe pressures less than 30mmHg
  • Unwilling to participate or receive injectable treatment or unable to keep appointments
  • Non-English or Non-Spanish speakers
  • Pregnant or planning to become pregnant

结局指标

主要结局

Change in HbA1c

时间窗: 6 months

Mean change in HbA1c from baseline to end of treatment

次要结局

  • Glycemic control(6 months)
  • Proportion of patients with emergency department visits(6 months)
  • Cost of glycemic management during study(6 months)
  • Foot ulcer and/or wound healing(6 months)
  • Patient reported satisfaction with diabetes treatment(6 months)
  • Patient reported health status(6 months)
  • Proportion of days covered score(6 months)
  • Proportion of patients with hospitalization(6 months)
  • Frequency of invasive procedures(6 months)
  • Number of outpatient visits(6 months)
  • Number of casts and boots used for treatment(6 months)
  • Overall hospital incurred patient-specific cost(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Uma Gunasekaran

Assistant Professor, Internal Medicine

University of Texas Southwestern Medical Center

研究点 (1)

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