NCT06296485

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2024Jan 2028

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

April 22, 2025

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

February 29, 2024

Last Update Submit

April 21, 2025

Conditions

Diabetes Mellitus, Type 2Hypoglycemia

Keywords

HypoglycemiaDiabetes EducationContinuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Self-reported hypoglycemia

    6 and 12 months after study start date

  • Hypoglycemia-related utilization

    6 and 12 months after study start date

  • Diabetes Distress

    6 and 12 months after study start date

  • Hypoglycemia Confidence

    6 and 12 months after study start date

  • Hypoglycemia Distress

    6 and 12 months after study start date

Other Outcomes (4)

  • Technology Proficiency

    6 and 12 months after study start date

  • Confidence in Adjusting Insulin

    6 and 12 months after study start date

  • Insulin Adjustment

    6 and 12 months after study start date

  • +1 more other outcomes

Study Arms (2)

Group Education Sessions

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

SAGE Group SessionsBEHAVIORAL

Participants enroll in 3 educational group sessions and receive CGMs

Group Education Sessions
Usual CareOTHER

Participants continue to receive usual care (Control Arm)

Usual Care

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente Fremont

Fremont, California, 94538, United States

RECRUITING

Kaiser Permanente San Jose

San Jose, California, 94538, United States

RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

RECRUITING

Kaiser Permanente - Union City

Union City, California, 94587, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard W Grant, MD MPH

    Kaiser Permanente Northern California - Division of Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Gonzalez

CONTACT

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

Nancy W Charvat-Aguilar

CONTACT

nancy.x.charvat-aguilar@kp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2-arm pragmatic randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

April 22, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)