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NCT04585191: RETRO-DM

Reducing Treatment Risk in Older Adults With Diabetes

Completed NA Results posted Last updated 21 March 2025
What this trial tests

NA trial testing Conversation Aid in Type 2 Diabetes Treated With Insulin in 450 participants. Completed in 1 September 2024.

Timeline
2 November 2020
Primary endpoint
30 March 2024
1 September 2024

Quick facts

Lead sponsorKaiser Permanente
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposehealth services research
Enrollment450
Start date2 November 2020
Primary completion30 March 2024
Estimated completion1 September 2024
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kaiser Permanente — full company profile →

Who can join

75 and older, any sex, with Type 2 Diabetes Treated With Insulin or Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing Primary · 6 months after initial primary care visit

Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from SU to other oral medicine less associated with hypoglycemia).

GroupValue95% CI
Pre-Visit Conversation Aid34
General Health Education Handout21
Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia Primary · Preceding 6 month period (asked 6 months after initial primary care visit)

Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else

GroupValue95% CI
Pre-Visit Conversation Aid10
General Health Education Handout13

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Diabetes Deprescribing in Older Adults: A Randomized Clinical Trial.
    Grant RW, Peterson I, McCloskey JM, Lipska KJ, et al · · 2025 · cited 5× · PMID 40549370 · DOI 10.1001/jamainternmed.2025.2015

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Treated With Insulin

Currently open trials in the same condition.

Other Kaiser Permanente trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04585191.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing