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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
Participants enroll in 3 educational group sessions and receive CGMs
Participants continue to receive usual care (Control Arm)
Kaiser Permanente Fremont
Fremont, California, United States
COMPLETEDKaiser Permanente Sacramento
Sacramento, California, United States
RECRUITINGKaiser Permanente San Jose
San Jose, California, United States
COMPLETEDKaiser Permanente San Leandro
San Leandro, California, United States
COMPLETEDKaiser Permanente Santa Clara
Santa Clara, California, United States
COMPLETEDKaiser Permanente - Union City
Union City, California, United States
COMPLETEDHypoglycemia 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
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