Safer Aging With Diabetes Monitoring

Part of paid clinical trials in Fremont, California.

Sponsor
Kaiser Permanente
Study ID
NCT06296485
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
75 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Oct 2024
Primary completion
Mar 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Kaiser Permanente FremontFremontCalifornia94538
Ilana A Peterson
Kaiser Permanente San JoseSan JoseCalifornia94538
Carolina Gonzalez
[email protected]
866-206-2969
Kaiser Permanente San LeandroSan LeandroCalifornia94577
Ilana A Peterson
Kaiser Permanente - Union CityUnion CityCalifornia94587
Ilana A Peterson

Find similar trials in Fremont, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Kaiser Permanente Fremont· Fremont, CAKaiser Permanente San Jose· San Jose, CAKaiser Permanente San Leandro· San Leandro, CAKaiser Permanente - Union City· Union City, CA

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