Diabetes Mellitus, Type 2, Hypoglycemia
Conditions
Keywords
Hypoglycemia, Diabetes Education, Continuous Glucose Monitor
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.
Interventions
BEHAVIORALSAGE Group Sessions
Participants enroll in 3 educational group sessions and receive CGMs
OTHERUsual Care
Participants continue to receive usual care (Control Arm)
Sponsors
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants
Intervention model description
2-arm pragmatic randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia aggregate outcome | 6 and 12 months after study start date | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported hypoglycemia | 6 and 12 months after study start date | This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others) |
| Hypoglycemia-related utilization | 6 and 12 months after study start date | This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events) |
| Diabetes Distress | 6 and 12 months after study start date | This outcome will compare responses to the 2-item, validated Diabetes Distress survey |
| Hypoglycemia Confidence | 6 and 12 months after study start date | This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey |
| Hypoglycemia Distress | 6 and 12 months after study start date | This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey |
Countries
United States
Contacts
CONTACTCarolina Gonzalez
CONTACTEmma M Fernandez
PRINCIPAL_INVESTIGATORRichard W Grant, MD MPH
Kaiser Permanente Northern California - Division of Research
Outcome results
None listed