Clinical trial NCT06296485: Safer Aging With Diabetes Monitoring
Official title: Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypoglycemia
Keywords: Hypoglycemia
Diabetes Education
Continuous Glucose Monitor
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-03-06
Enrollment: 360
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm pragmatic randomized clinical trial
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Hypoglycemia aggregate outcome
timeFrame: 6 and 12 months after study start date
Secondary outcomes:
measure: Self-reported hypoglycemia
timeFrame: 6 and 12 months after study start date
measure: Hypoglycemia-related utilization
timeFrame: 6 and 12 months after study start date
measure: Diabetes Distress
timeFrame: 6 and 12 months after study start date
measure: Hypoglycemia Confidence
timeFrame: 6 and 12 months after study start date
measure: Hypoglycemia Distress
timeFrame: 6 and 12 months after study start date
Other outcomes:
measure: Technology Proficiency
timeFrame: 6 and 12 months after study start date
measure: Confidence in Adjusting Insulin
timeFrame: 6 and 12 months after study start date
measure: Insulin Adjustment
timeFrame: 6 and 12 months after study start date
measure: Caregiver Action
timeFrame: 6 and 12 months after study start date
Locations:
city: Fremont
country: United States
facility: Kaiser Permanente Fremont
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro
state: California
city: Union City
country: United States
facility: Kaiser Permanente - Union City
state: California
Study officials:
affiliation: Kaiser Permanente Northern California - Division of Research
name: Richard W Grant, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: