Safer Aging With Diabetes Monitoring

Официальное название

Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes

Обзор

Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

Подробное описание

The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.

Вмешательства

• Поведенческое SAGE Group Sessions
  Participants enroll in 3 educational group sessions and receive CGMs
• Другое Usual Care
  Participants continue to receive usual care (Control Arm)

Первичные конечные точки

• Hypoglycemia aggregate outcome [Срок оценки: 6 and 12 months after study start date]

Вторичные конечные точки (5)

• Self-reported hypoglycemia [Срок оценки: 6 and 12 months after study start date]
• Hypoglycemia-related utilization [Срок оценки: 6 and 12 months after study start date]
• Diabetes Distress [Срок оценки: 6 and 12 months after study start date]
• Hypoglycemia Confidence [Срок оценки: 6 and 12 months after study start date]
• Hypoglycemia Distress [Срок оценки: 6 and 12 months after study start date]

Критерии участия

Критерии включения

• Age 75 years and older
• Diagnosis of Type 2 Diabetes
• Current treatment with insulin
• Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)
• Able to communicate in English
• Able to access email and the Internet

Критерии исключения

• On renal dialysis
• Dementia
• Pacemaker or Automatic Implantable Cardioverter Defibrillator
• Using insulin pump
• Severe Mental Illness
• Severe Visual Impairment
• In Hospice
• Current or recent CGM use

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 6 центров

• Kaiser Permanente Fremont — Fremont
• Kaiser Permanente Sacramento — Sacramento
• Kaiser Permanente San Jose — San Jose
• Kaiser Permanente San Leandro — San Leandro
• Kaiser Permanente Santa Clara — Santa Clara
• Kaiser Permanente - Union City — Union City

Идентификаторы

NCT: NCT06296485 · IRB-1996616 · R01DK134446

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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