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Safer Aging With Diabetes Monitoring

NCT06296485 · Kaiser Permanente
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: single
Age groups: older_adult
Timeline
Starts: 2024-05-01
Estimated completion: 2028-01-31
Last updated: 2025-04-22
Interventions
Behavioral: SAGE Group SessionsOther: Usual Care
Primary outcomes
  • Hypoglycemia aggregate outcome (6 and 12 months after study start date)
Sponsor
Kaiser Permanente · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactCarolina Gonzalez · contact · Susana.C.Gonzalez@kp.org · 866-206-2969
ContactNancy W Charvat-Aguilar · contact · nancy.x.charvat-aguilar@kp.org
InvestigatorRichard W Grant, MD MPH · principal_investigator, Kaiser Permanente Northern California - Division of Research
All locations (4)
Kaiser Permanente FremontRecruiting
Fremont, California, United States
Kaiser Permanente San JoseRecruiting
San Jose, California, United States
Kaiser Permanente San LeandroRecruiting
San Leandro, California, United States
Kaiser Permanente - Union CityRecruiting
Union City, California, United States
Safer Aging With Diabetes Monitoring · TrialPath