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Behavioral Intervention

Safer Insulin Management for Older Adults with Type 2 Diabetes (SAGE Trial)

N/A
Recruiting
Led By Richard W Grant, MD MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 75 years and older
Current treatment with insulin
Must not have
Severe Visual Impairment
Dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months after study start date
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new approach for prescribing insulin to older adults with type 2 diabetes who are at high risk for severe hypoglycemia. The approach involves using continuous glucose monitoring and

Who is the study for?
This trial is for older adults aged 75 and above with type 2 diabetes who are currently on insulin treatment. Participants should have experienced low blood sugar in the past year, be able to communicate in English, and have access to email and the Internet.
What is being tested?
The study tests a new educational program using continuous glucose monitoring to help prevent severe low blood sugar episodes. Participants will either attend SAGE group sessions, combine these sessions with support from a diabetes pharmacist, or receive usual care without additional education.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at sensor sites for glucose monitoring and possible anxiety or stress from continuous health tracking. Usual care likely has no additional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 75 years old or older.
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I am currently being treated with insulin.
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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe difficulty seeing.
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I have been diagnosed with dementia.
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I am currently on kidney dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months after study start date
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months after study start date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypoglycemia aggregate outcome
Secondary study objectives
Diabetes Distress
Hypoglycemia Confidence
Hypoglycemia Distress
+2 more
Other study objectives
Caregiver Action
Confidence in Adjusting Insulin
Insulin Adjustment
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group Education SessionsExperimental Treatment1 Intervention
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).
Group II: Usual CareActive Control1 Intervention
Participants allocated to the control arm will continue with usual care.

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,702,027 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,322,897 Total Patients Enrolled
Richard W Grant, MD MPHPrincipal InvestigatorKaiser Permanente Northern California - Division of Research
6 Previous Clinical Trials
2,683 Total Patients Enrolled
~240 spots leftby Mar 2027
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