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NCT Number: NCT06296485

Safer Aging With Diabetes Monitoring

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Fremont, Fremont, California, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAGE Group Sessions

Behavioral

Participants enroll in 3 educational group sessions and receive CGMs

Usual Care

Other

Participants continue to receive usual care (Control Arm)

Primary outcomes

  1. Hypoglycemia aggregate outcome

    Time frame: 6 and 12 months after study start date

    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

Secondary outcomes

  1. Self-reported hypoglycemia

    Time frame: 6 and 12 months after study start date

    This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others)

  2. Hypoglycemia-related utilization

    Time frame: 6 and 12 months after study start date

    This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events)

  3. Diabetes Distress

    Time frame: 6 and 12 months after study start date

    This outcome will compare responses to the 2-item, validated Diabetes Distress survey

  4. Hypoglycemia Confidence

    Time frame: 6 and 12 months after study start date

    This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey

  5. Hypoglycemia Distress

    Time frame: 6 and 12 months after study start date

    This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey

Other outcomes

  1. Technology Proficiency

    Time frame: 6 and 12 months after study start date

    This outcome will compare responses to a 3-item subset of the validated Technology Proficiency survey

  2. Confidence in Adjusting Insulin

    Time frame: 6 and 12 months after study start date

    This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey

  3. Insulin Adjustment

    Time frame: 6 and 12 months after study start date

    This outcome will assess patient self-report of changes to insulin regimen in preceding 6 months

  4. Caregiver Action

    Time frame: 6 and 12 months after study start date

    This outcome will assess patient self-report of caregiver taking action to address low blood sugar in preceding 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Gonzalez

CONTACT

[email protected]

866-206-2969

Nancy W Charvat-Aguilar

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: SAGE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2024
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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