Safer Aging With Diabetes Monitoring

Diabetes Mellitus, Type 2 Clinical Trial

— SAGE  

Official title:

Pragmatic Clinical Trial of Continuous Glucose Monitoring-based Interventions for Safe Insulin Use in High-Risk Older Adults With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296485
• Other study ID #: IRB-1996616
• Secondary ID: R01DK134446
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: May 2024
• Source: Kaiser Permanente
• Contact: Ilana Peterson, MPH
• Phone: 866-206-2969
• Email: Ilana.A.Peterson[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 3-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants), 2) Group-based, three-session education intervention (CGM provided to participants) plus 1:1 consultation with a diabetes pharmacist, and 3) 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypoglycemia

Intervention

Behavioral:
• SAGE Group Sessions
Participants enroll in 3 educational group sessions and receive CGMs
• SAGE Group Sessions + Diabetes Pharmacist
Participants enroll in 3 educational group sessions, receive CGMs, and meet 1:1 with Diabetes Pharmacist

Other:
• Usual Care
Participants continue to receive usual care (Control Arm)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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