An interventional study of SAGE Group Sessions and Usual Care in Diabetes Mellitus, Type 2 and Hypoglycemia, sponsored by Kaiser Permanente. Recruiting at 6 sites in United States. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 360 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Participants allocated to the control arm will continue with usual care.
Other: Usual Care
Participants enroll in 3 educational group sessions and receive CGMs
Participants continue to receive usual care (Control Arm)
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
Time frame: 6 and 12 months after study start date
Self-reported hypoglycemia
This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others)
Time frame: 6 and 12 months after study start date
Hypoglycemia-related utilization
This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events)
Time frame: 6 and 12 months after study start date
Diabetes Distress
This outcome will compare responses to the 2-item, validated Diabetes Distress survey
Time frame: 6 and 12 months after study start date
Hypoglycemia Confidence
This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey
Time frame: 6 and 12 months after study start date
Hypoglycemia Distress
This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey
Time frame: 6 and 12 months after study start date
Technology Proficiency
This outcome will compare responses to a 3-item subset of the validated Technology Proficiency survey
Time frame: 6 and 12 months after study start date
Confidence in Adjusting Insulin
This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey
Time frame: 6 and 12 months after study start date
Insulin Adjustment
This outcome will assess patient self-report of changes to insulin regimen in preceding 6 months
Time frame: 6 and 12 months after study start date
Caregiver Action
This outcome will assess patient self-report of caregiver taking action to address low blood sugar in preceding 6 months
Time frame: 6 and 12 months after study start date
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Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Sep 2027, 40 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 40 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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