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Conversation Aid for Diabetes Management (RETRO-DM 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
Type 2 diabetes with last measured HbA1c ≤ 8.0%
Age ≥ 75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following the first study-related visit
Awards & highlights

RETRO-DM Trial Summary

This trial will study whether preparing patients for their doctor's visit makes them more likely to have a discussion about their insulin usage, and whether this discussion leads to a decrease in hypoglycemia.

Who is the study for?
This trial is for people aged 75 or older with type 2 diabetes who are members of Kaiser Permanente Northern California. They must be on insulin or sulfonylureas (SUs) and have an HbA1c level of 8.0% or less. It's not for those who can't communicate in English, give informed consent, participate in decision making due to cognitive issues, or are excluded by their primary care provider.Check my eligibility
What is being tested?
The study tests if educating doctors and preparing patients before visits helps safely reduce the use of insulin among older adults at risk for low blood sugar. One group gets a conversation aid to prepare them, while another receives just educational handouts.See study design
What are the potential side effects?
Since this trial involves education and conversation aids rather than medications, there aren't direct side effects like you'd expect from drugs. However, changes in medication regimens as a result could lead to variations in blood sugar levels.

RETRO-DM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes with a recent HbA1c level of 8.0% or lower.
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I am 75 years old or older.
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I am currently taking insulin or sulfonylureas for my diabetes.

RETRO-DM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following the first study-related visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year following the first study-related visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Outcome: Number of Participants with glycemic regimen de-prescribing
Patient-Reported Outcome: Number of Participants with Self-Reported Hypoglycemia
Secondary outcome measures
Number of Participants with Hypoglycemic-related hospitalizations
Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire
Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions
+1 more
Other outcome measures
HbA1c Change from baseline to study completion, an average of 1 year

RETRO-DM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-Visit Conversation AidExperimental Treatment1 Intervention
Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps.
Group II: General Health Education HandoutActive Control1 Intervention
Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,997,008 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,348 Total Patients Enrolled
Richard W Grant, MD MPHPrincipal InvestigatorDivision of Research, Kaiser Permanente Northern California
6 Previous Clinical Trials
2,593 Total Patients Enrolled

Media Library

Conversation Aid Clinical Trial Eligibility Overview. Trial Name: NCT04585191 — N/A
Type 2 Diabetes Research Study Groups: Pre-Visit Conversation Aid, General Health Education Handout
Type 2 Diabetes Clinical Trial 2023: Conversation Aid Highlights & Side Effects. Trial Name: NCT04585191 — N/A
Conversation Aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585191 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the fundamental outcomes that this clinical trial is aiming to assess?

"The primary outcome measure of this clinical trial will be tracked over a 6-month span following the initial patient visit. This metric is defined as Patient Reported Outcome: Number of Participants with Self-Reported Hypoglycemia. Secondary outcomes include changes in scores on the RAND and Diabetes Treatment Satisfaction Questionnaires, as well as incidents of hypoglycemic related hospitalizations within the same time frame."

Answered by AI

What is the maximum capacity of participants in this research?

"Affirmative. According to clinicaltrials.gov, this experimental treatment is actively looking for participants; the post was published on November 2nd 2020 and recently updated in December 7th 2021. The study requires a total of 440 candidates from 4 distinct medical centres."

Answered by AI

Is this scientific research currently accepting volunteers?

"Per information posted on clinicaltrials.gov, this research endeavour is presently enrolling participants; its initial posting date was November 2nd 2020 and the data was most recently updated on December 7th 2021."

Answered by AI

Are there ample locations in the US where this clinical experiment is currently taking place?

"This clinical trial has 4 major sites in Union City, Vallejo, and San Francisco as well as additional locations. More specifically these are located at Kaiser Permanente South San Francisco and 3 other centres."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Kaiser Permanente Union City
Kaiser Permanente South San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Reducing Treatment Risk in Older Adults With Diabetes
2020. "Reducing Treatment Risk in Older Adults With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585191.
All > Hypoglycemia
~100 spots leftby Apr 2025
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