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Type 2 Diabetes Mellitus With HypoglycemiaNCT05263310

Prepare for Your Diabetes Care

A study testing Prepare for Your Diabetes Care in people with Type 2 Diabetes Mellitus With Hypoglycemia and Aging, run by Kaiser Permanente at 1 site 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

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in… Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Prepare for Your Diabetes Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
672 participants
Where
1 siteUnited States
Study dates
25 Apr 2022to 8 Aug 2025
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 HbA1c ≤ 8.0%
  • Currently prescribed insulin and/or SUs
  • Kaiser Permanente Northern California member

Who cannot join

  • Unable to communicate in English
  • Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits
  • Excluded by their primary care provider

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente - Oakland Medical Center

    Oakland, California, 94577

Other trials in United States

About this study

Official title: Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

Read the detailed description

In this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible Kaiser Permanente Northern California members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%). Participants randomly allocated to the intervention arm will view the Prepare for Your Diabetes Care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an Action Plan handout. Participants randomly allocated to the control arm will continue with usual care. All participants will complete baseline, 6-month, and 12-month surveys. The hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Being tested
Prepare for Your Diabetes Care, Usual Care
Medical subject headings
Patient Participation

What participants receive

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

  • Prepare for Your Diabetes CareBehavioural

    Educational video and Action Plan handout

  • Usual CareBehavioural

    Control arm patients will continue with usual care

Study groups in NCT05263310
Study groupRoleWhat they receive
Educational Video and Action Plan handoutExperimentalPatients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout. This program 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 with the participant's primary care provider.
Receives: Behavioral: Prepare for Your Diabetes Care
Usual CareActive comparatorPatients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys
Receives: Behavioral: Usual Care

What is being measured

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

  1. Any Incidence of Hypoglycemia

    Any one of the following hypoglycemia event measures: 1] Self-report to survey question: Have you had three or more symptomatic hypoglycemia episodes in past 4 weeks (survey administered at month 6 and month 12); 2] Self-report to survey question: Have you had one or more severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else (survey administered at month 6 and month 12); 3 \& 4] Clinical record of any emergency department or hospital admission with primary admitting diagnosis of hypoglycemia during the 12-month study period

    Measured: 12 months after baseline date

Secondary outcomes (8)

  1. Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia

    Patient report of any self-reported severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else

    Measured: Preceding 6-month period (asked 6 and 12 months after first study-related visit)]

  2. Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia

    Patient report of three or more self-reported symptomatic episodes in past 4 weeks (measured at 6- and 12-months)

    Measured: Preceding 1-month period (asked 6 and 12 months after first study-related visit)

  3. Patient-Reported Outcome: Problem Areas in Diabetes

    5-item Problem Areas in Diabetes (PAID-5) + Worry about Hypoglycemia

    Measured: 6 and 12 months following the first study-related visit

  4. Clinical Utilization Outcome: Hypoglycemic-related Admissions to Emergency Department or Hospital

    Hypoglycemic-related admissions in the 6 months and 12 months following the first study-related visit

    Measured: 6 and 12 months following the first study-related visit

  5. Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire

    5-item RAND Patient Satisfaction Questionnaire (PSQ III)

    Measured: 6 and 12 months following the first study-related visit

  6. Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions

    5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) Survey Instrument

    Measured: 6 and 12 months following the first study-related visit

  7. Patient-Centered Outcome: Active Patient Participation During Primary Care Visits

    In a subset of patients (n = 40 in each arm, total n = 80), we will audio-record a selected primary care visit. Visit transcripts will be analyzed using the Active Patient Participation Coding Scheme [Coding Instrument] and utterances per unit time [Outcome Measure] demonstrating active patient participation related to diabetes management will be compared between arms.

    Measured: 6 - 12 months following the first study-related visit

  8. Medication-Related Outcome: Aggregate Measure of Diabetes Medication Deprescribing

    Aggregate measure of diabetes medication deprescribing between baseline and 12-month follow-up, defined as any combination of:

    • Discontinuation of either insulin or sulfonylurea (SU),
    • Reduction in dose of insulin or SU,
    • 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: 12 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 posted2 Mar 2022
  2. Study start25 Apr 2022
  3. Primary completion8 Aug 2025
  4. Study completion8 Aug 2025

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
pragmatic, clinical efficacy, patient-level randomized clinical trial
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263310
Sponsor's protocol ID
IRB-1635322
Other IDs
R01AG068133
Status last verified
Jun 2026
First submitted
7 Feb 2022
Last updated
20 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee AK, Mejia JJ, Ferguson C, Li BH, Grant RW, Sudore RL. Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial. Contemp Clin Trials. 2025 Jun;153:107913. doi: 10.1016/j.cct.2025.107913. Epub 2025 Apr 11.

    PubMed 40222399

Questions about this trial

What is this clinical trial studying?

A study testing Prepare for Your Diabetes Care in people with Type 2 Diabetes Mellitus With Hypoglycemia and Aging, run by Kaiser Permanente at 1 site 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 20 Oct 2026). 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?

Any Incidence of Hypoglycemia (time frame: 12 months after baseline date). 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 NCT05263310, 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 20 Oct 2026.

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