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临床试验/NCT03908762
NCT03908762Unknown不适用

Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration

Amalgam Rx, Inc.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change in A1C

研究概览

简要总结

The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c <7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec)
  • HgbA1c 8 or above
  • GFR >60 ml/min within the last 12 months
  • English speaking, informed consent
  • Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above)
  • Currently performs at least 3 fasting fingerstick glucose measurements/week
  • Have a PCP within the KU Health System

排除标准

  • Diagnosis of hypoglycemic unawareness within 6 months of enrollment
  • Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
  • Recent (within the last 6 months)/current use of non-topical steroids
  • Insulin requirements in excess of 1U/kg per day
  • Use of pioglitazone or another thiazolidinedione (TZD)
  • In the opinion of the provider, HgbA1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.

研究组 & 干预措施

iSage

Experimental

The provider will choose a treatment algorithm embedded within the app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The app is downloaded by the patient while in the examination room, and the patient is instructed to perform daily fasting glucose fingerstick measurements and follow the app's recommendations for insulin adjustment. Data on telephone or visit contact with a healthcare provider will be collected via the EMR. Hypoglycemic events (defined as blood glucose <70 mg/dl, measured or perceived) are recorded in the iSage application as well as patient report. Providers are asked to review the patients transmitted blood sugar logs as necessary, and those reviews are recorded. Return visits are managed by the HCP and will be logged as resource utilization.

干预措施: iSage App with connected glucometer (Device)

Conventional Management

Active Comparator

Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. In the case of glargine or detemir (Basaglar, Lantus, Levemir) adjustments of 1 unit of insulin/day are made until the fasting blood sugars (2 of 3 consecutive values) are 80-130 mg/dl. In the instance of Toujeo or Tresiba, adjustments of 2 units are made every 5 days. Volunteers will have meters downloaded (or interviewed where necessary) to obtain data on fasting blood sugar and episodes of hypoglycemia (perceived or measured <70 mg/dl). The PCP is free to request glucose logs and set return appointments as needed to manage the patient.

干预措施: Magnet (Behavioral)

结局指标

主要结局

Change in A1C

时间窗: 3 Months

Mean and Median Change from Baseline

次要结局

  • A1C in Target(Baseline to 3 months)
  • Rate of Hypoglycemia(Baseline to 3 months)

研究者

发起方
Amalgam Rx, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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