Recruiting

Diabetes Monitoring

Sponsor:

Kaiser Permanente

Code:

NCT06296485

Conditions

Diabetes Mellitus, Type 2

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

SAGE Group Sessions

Usual Care

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Hypoglycemia

Study ID

NCT06296485

Start date

May 1, 2024

Status verified date

Feb, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

active comparator: Usual Care

Participants allocated to the control arm will continue with usual care.

Interventions

SAGE Group Sessions

Participants enroll in 3 educational group sessions and receive CGMs

Usual Care

Participants continue to receive usual care (Control Arm)

Primary outcome measure

  • Hypoglycemia aggregate outcome [ Time Frame: 6 and 12 months after study start date ]

Central Contacts and Locations

Central contacts

Carolina Gonzalez

866-206-2969Susana.C.Gonzalez@kp.org

Emma M Fernandez

866-206-2969emma.m.fernandez@kp.org

Locations

Kaiser Permanente Sacramento

Recruiting

Sacramento, California, United States, 95814

Contacts

Emma Fernandez

emma.m.fernandez@kp.org

More Information

Sponsor

Kaiser Permanente

Last update posted

Aug 4, 2026

Last verified

Feb, 2026

Keywords

  • Hypoglycemia
  • Diabetes Education
  • Continuous Glucose Monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-08-04.