Safer Aging With Diabetes Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAGE Group Sessions, Usual Care.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Hypoglycemia. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
Overview
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.
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.
Interventions
- Behavioral SAGE Group Sessions
Participants enroll in 3 educational group sessions and receive CGMs - Other Usual Care
Participants continue to receive usual care (Control Arm)
Primary outcome measures
- Hypoglycemia aggregate outcome [Time frame: 6 and 12 months after study start date]
Secondary outcome measures (5)
- Self-reported hypoglycemia [Time frame: 6 and 12 months after study start date]
- Hypoglycemia-related utilization [Time frame: 6 and 12 months after study start date]
- Diabetes Distress [Time frame: 6 and 12 months after study start date]
- Hypoglycemia Confidence [Time frame: 6 and 12 months after study start date]
- Hypoglycemia Distress [Time frame: 6 and 12 months after study start date]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 6 centers
- Kaiser Permanente Fremont — Fremont
- Kaiser Permanente Sacramento — Sacramento
- Kaiser Permanente San Jose — San Jose
- Kaiser Permanente San Leandro — San Leandro
- Kaiser Permanente Santa Clara — Santa Clara
- Kaiser Permanente - Union City — Union City
Identifiers
NCT: NCT06296485 · IRB-1996616 · R01DK134446