Safer Aging With Diabetes Monitoring (SAGE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Hypoglycemia
• Intervention / Treatment: Behavioral: SAGE Group Sessions; Other: Usual Care

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy W Charvat-Aguilar; Email: nancy.x.charvat-aguilar@kp.org
• Study Contact Backup: Name: Carolina Gonzalez; Phone Number: 866-206-2969; Email: susana.c.gonzalez@kp.org

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Kaiser Permanente Fremont
      • Contact: Ilana A Peterson
    • San Jose, California, United States, 94538
      • Recruiting
      • Kaiser Permanente San Jose
      • Contact: Carolina Gonzalez; Phone Number: 866-206-2969; Email: susana.c.gonzalez@kp.org
    • San Leandro, California, United States, 94577
      • Recruiting
      • Kaiser Permanente San Leandro
      • Contact: Ilana A Peterson
    • Union City, California, United States, 94587
      • Recruiting
      • Kaiser Permanente - Union City
      • Contact: Ilana A Peterson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Education Sessions; Participants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors [CGMs] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 & 3).	Behavioral: SAGE Group Sessions; Participants enroll in 3 educational group sessions and receive CGMs
Active Comparator: Usual Care; Participants allocated to the control arm will continue with usual care.	Other: Usual Care; Participants continue to receive usual care (Control Arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia aggregate outcome	This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others) and/or hypoglycemia-related utilization (emergency department, hospital or outpatient new events) 6- and 12-months after enrollment	6 and 12 months after study start date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported hypoglycemia	This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others)	6 and 12 months after study start date
Hypoglycemia-related utilization	This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events)	6 and 12 months after study start date
Diabetes Distress	This outcome will compare responses to the 2-item, validated Diabetes Distress survey	6 and 12 months after study start date
Hypoglycemia Confidence	This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey	6 and 12 months after study start date
Hypoglycemia Distress	This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey	6 and 12 months after study start date

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology Proficiency	This outcome will compare responses to a 3-item subset of the validated Technology Proficiency survey	6 and 12 months after study start date
Confidence in Adjusting Insulin	This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey	6 and 12 months after study start date
Insulin Adjustment	This outcome will assess patient self-report of changes to insulin regimen in preceding 6 months	6 and 12 months after study start date
Caregiver Action	This outcome will assess patient self-report of caregiver taking action to address low blood sugar in preceding 6 months	6 and 12 months after study start date

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Richard W Grant, MD MPH, Kaiser Permanente Northern California - Division of Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Hypoglycemia; Continuous Glucose Monitor; Diabetes Education
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: IRB-1996616; R01DK134446 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No