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Completed

NCT Number: NCT05263310

Prepare for Your Diabetes Care

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.

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Key information

Conditions

Type 2 Diabetes Mellitus With Hypoglycemia Aging Behavior Health Behavior Patient Acceptance of Health Care Patient Activation Patient Participation Treatment Adherence and Compliance

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente - Oakland Medical Center

Oakland, California, 94577, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 75 years
  • Type 2 diabetes with last measured HbA1c ≤ 8.0%
  • Currently prescribed insulin and/or SUs
  • Kaiser Permanente Northern California member

Exclusion criteria

  • 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

Treatment and study plan

Prepare for Your Diabetes Care

Behavioral

Educational video and Action Plan handout

Usual Care

Behavioral

Control arm patients will continue with usual care

Primary outcomes

  1. Any incidence of hypoglycemia

    Time frame: 12 months after baseline date

    Any one of the following hypoglycemia event measures:

    • 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)
    • 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)
    • Clinical record of any emergency department or hospital admission with primary admitting diagnosis of hypoglycemia during the 12-month study period

Secondary outcomes

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

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

    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

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

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

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

  3. Patient-Reported Outcome: Problem Areas in Diabetes

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

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

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

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

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

  5. Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire

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

    5-item RAND Patient Satisfaction Questionnaire (PSQ III)

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

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

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

  7. Patient-Centered Outcome: Active Patient Participation during primary care visits

    Time frame: 6 - 12 months following the first study-related visit

    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.

  8. Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing

    Time frame: 12 months following the first study-related visit

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

    • Discontinuation of either insulin or 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).

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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