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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK134446 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Education Sessions | Experimental | 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). |
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| Usual Care | Active Comparator | Participants allocated to the control arm will continue with usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE Group Sessions | Behavioral | Participants enroll in 3 educational group sessions and receive CGMs |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hypoglycemia-related utilization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Confidence in Adjusting Insulin | This outcome will assess confidence in adjusting insulin across the 3 study arms using a 3-item survey |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Gonzalez | Contact | 866-206-2969 | Susana.C.Gonzalez@kp.org | |
| Nancy W Charvat-Aguilar | Contact | nancy.x.charvat-aguilar@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| Richard W Grant, MD MPH | Kaiser Permanente Northern California - Division of Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Fremont | Recruiting | Fremont | California | 94538 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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2-arm pragmatic randomized clinical trial
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Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants
| Usual Care | Other | Participants continue to receive usual care (Control Arm) |
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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 |
| Diabetes Distress | This outcome will compare responses to the 2-item, validated Diabetes Distress survey | 6 and 12 months after study start date |
| Hypoglycemia Confidence | This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey | 6 and 12 months after study start date |
| Hypoglycemia Distress | This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey | 6 and 12 months after study start date |
| 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 | 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 | 6 and 12 months after study start date |
| Kaiser Permanente San Jose | Recruiting | San Jose | California | 94538 | United States |
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| Kaiser Permanente San Leandro | Recruiting | San Leandro | California | 94577 | United States |
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| Kaiser Permanente - Union City | Recruiting | Union City | California | 94587 | United States |
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| D004700 | Endocrine System Diseases |