Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
Kaiser Permanente
Summary
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.
Description
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…
Eligibility
- Age range
- 75+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Interventions
- BehavioralSAGE Group Sessions
Participants enroll in 3 educational group sessions and receive CGMs
- OtherUsual Care
Participants continue to receive usual care (Control Arm)
Locations (4)
- Kaiser Permanente FremontFremont, California
- Kaiser Permanente San JoseSan Jose, California
- Kaiser Permanente San LeandroSan Leandro, California
- Kaiser Permanente - Union CityUnion City, California