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Type 2 Diabetes Treated With InsulinRETRO-DMNCT04585191

Reducing Treatment Risk in Older Adults With Diabetes

A study testing Conversation Aid in people with Type 2 Diabetes Treated With Insulin and Hypoglycemia, run by Kaiser Permanente at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Conversation Aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
4 sitesUnited States
Study dates
2 Nov 2020to 1 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Kaiser Permanente South San Francisco

    San Francisco, California, 94080

  • Kaiser Permanente Northern California

    San Leandro, California, 94577

  • Kaiser Permanente Union City

    Union City, California, 94587

  • Kaiser Permanente Vallejo

    Vallejo, California, 94589

Other trials in United States

About this study

Official title: Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation

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.

Read the detailed description

In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing [Intervention] or a general health education handout ("Embracing Life as You Age") [Attention Control]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Being tested
Conversation Aid, Attention Control Educational Handout
Keywords
clinical trial
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conversation AidBehavioural

    Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their primary care physician (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.

  • Attention Control Educational HandoutOther

    Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Study groups in NCT04585191
Study groupRoleWhat they receive
Pre-Visit Conversation AidExperimentalPatients 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 primary care physician (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.
Receives: Behavioral: Conversation Aid
General Health Education HandoutActive comparatorPatients 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.
Receives: Other: Attention Control Educational Handout

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing

    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).

    Measured: 6 months after initial primary care visit

  2. Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia

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

    Measured: Preceding 6 month period (asked 6 months after initial primary care visit)

Secondary outcomes (4)

  1. Diabetes Treatment Satisfaction Questionnaire Scores

    Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [8 items, scores 0 - 36, higher score is better]

    Measured: Asked 6 months after initial primary care visit

  2. Number of Participants With Hypoglycemic-related Hospitalizations

    Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit.

    Measured: 6 months following the first study-related visit

  3. RAND Patient Satisfaction Questionnaire

    Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [5 item, score 5- 25, higher is worse]

    Measured: 6 months following the first study-related visit

  4. Perceived Efficacy in Patient - Physician Interactions

    Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions (5 - Item Survey, score 5-25, higher is better)

    Measured: 6 months following the first study-related visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start2 Nov 2020
  3. Primary completion30 Mar 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
There are two arms within the Comparative Effectiveness Randomized Clinical Trial (CE-RCT). All eligible primary care physicians (PCPs) will receive academic detailing. Eligible and consenting patients of these PCPs will be randomly allocated to intervention vs attention control arms grouped by PCP. (There will be a secondary, parallel comparison group to measure temporal trends in care for similar patients at other facilities in our care system not involved in the clinical trial.)
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585191
Sponsor's protocol ID
CDR-2019C1-16126
Acronym
RETRO-DM
Status last verified
Oct 2024
First submitted
28 Sep 2020
Last updated
21 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grant RW, Peterson I, McCloskey JM, Lipska KJ, Nugent J, Karter AJ, Gilliam LK. Diabetes Deprescribing in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):926-935. doi: 10.1001/jamainternmed.2025.2015.

    PubMed 40549370

Questions about this trial

What is this clinical trial studying?

A study testing Conversation Aid in people with Type 2 Diabetes Treated With Insulin and Hypoglycemia, run by Kaiser Permanente at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing (time frame: 6 months after initial primary care visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

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