Diabetes Mellitus, Type 2 Clinical Trial
— SAGEOfficial title:
Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes
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.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | January 31, 2028 |
Est. primary completion date | March 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Fremont | Fremont | California |
United States | Kaiser Permanente San Leandro | San Leandro | California |
United States | Kaiser Permanente - Union City | Union City | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Technology Proficiency | This outcome will compare responses to a 3-item subset of the validated Technology Proficiency survey | 6 and 12 months after study start date | |
Other | Confidence in Adjusting Insulin | This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey | 6 and 12 months after study start date | |
Other | Insulin Adjustment | This outcome will assess patient self-report of changes to insulin regimen in preceding 6 months | 6 and 12 months after study start date | |
Other | Caregiver Action | This outcome will assess patient self-report of caregiver taking action to address low blood sugar in preceding 6 months | 6 and 12 months after study start date | |
Primary | 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 | 6 and 12 months after study start date | |
Secondary | 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) | 6 and 12 months after study start date | |
Secondary | 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) | 6 and 12 months after study start date | |
Secondary | Diabetes Distress | This outcome will compare responses to the 2-item, validated Diabetes Distress survey | 6 and 12 months after study start date | |
Secondary | Hypoglycemia Confidence | This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey | 6 and 12 months after study start date | |
Secondary | Hypoglycemia Distress | This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey | 6 and 12 months after study start date |
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