N/A N=450 Randomized Double-blind Health Services Research

Reducing Treatment Risk in Older Adults With Diabetes

Type 2 Diabetes Treated With Insulin · Hypoglycemia · Primary Health Care · Polypharmacy

Bottom Line

View on ClinicalTrials.gov: NCT04585191 ↗

Enrolled (actual)

450

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing — 34; 21 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Conversation Aid (Behavioral); Attention Control Educational Handout (Other)
Age: Older Adult · 75+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing	34; 21	—
PRIMARY Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia	10; 13	—
SECONDARY Diabetes Treatment Satisfaction Questionnaire Scores	—	—
SECONDARY Number of Participants With Hypoglycemic-related Hospitalizations	—	—
SECONDARY RAND Patient Satisfaction Questionnaire	—	—
SECONDARY Perceived Efficacy in Patient - Physician Interactions	—	—

Summary

This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.

Eligibility Criteria

Inclusion Criteria

age ≥ 75 years
type 2 diabetes with last measured Hemoglobin A1c (HbA1c) ≤ 8.0%
currently prescribed insulin and/or sulfonylureas (SUs)
Kaiser Permanente Northern California member

Exclusion Criteria

Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded.
Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
Excluded by their primary care provider

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04585191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.