Improving diabetes management for older adults at risk of low blood sugar
Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
This study tests a new educational program using continuous glucose monitoring to help older adults with type 2 diabetes avoid dangerous low blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 4 sites (Fremont, California and 3 other locations) |
| Trial ID | NCT06296485 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance diabetes care for older adults aged 75 and above who have type 2 diabetes and are at risk for severe hypoglycemia. It evaluates a novel educational program that utilizes continuous glucose monitoring (CGM) to support safe insulin prescribing. Participants will be randomly assigned to either a group-based education intervention with CGM or to usual care without CGM. The study will measure the incidence of clinically significant hypoglycemia and assess patient-reported outcomes related to diabetes distress and self-efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 75 and above who have type 2 diabetes and are currently using insulin.
Not a fit: Patients who are on renal dialysis, have dementia, or are using insulin pumps may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of severe hypoglycemia in older adults with type 2 diabetes, improving their overall health and quality of life.
How similar studies have performed: While there have been studies on diabetes management in older adults, this specific approach using CGM for hypoglycemia prevention is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fremont, California and 3 other locations
- Kaiser Permanente Fremont — Fremont, California, United States (Recruiting)
- Kaiser Permanente San Jose — San Jose, California, United States (Recruiting)
- Kaiser Permanente San Leandro — San Leandro, California, United States (Recruiting)
- Kaiser Permanente - Union City — Union City, California, United States (Recruiting)
Study contacts
- Principal investigator: Richard W Grant, MD MPH — Kaiser Permanente Northern California - Division of Research
- Study coordinator: Carolina Gonzalez
- Email: Susana.C.Gonzalez@kp.org
- Phone: 866-206-2969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.