Prepare for Your Diabetes Care

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.

• 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

• Any Incidence of Hypoglycemia [12 months after baseline date]: 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

Secondary outcomes

• Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia [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
• Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia [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)
• Patient-Reported Outcome: Problem Areas in Diabetes [6 and 12 months following the first study-related visit]: 5-item Problem Areas in Diabetes (PAID-5) + Worry about Hypoglycemia
• Clinical Utilization Outcome: Hypoglycemic-related Admissions to Emergency Department or Hospital [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
• Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire [6 and 12 months following the first study-related visit]: 5-item RAND Patient Satisfaction Questionnaire (PSQ III)
• Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions [6 and 12 months following the first study-related visit]: 5-item Perceived Efficacy in Patient - Physician Interactions (PEPPI) Survey Instrument
• Patient-Centered Outcome: Active Patient Participation During Primary Care Visits [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.
• Medication-Related Outcome: Aggregate Measure of Diabetes Medication Deprescribing [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 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).

Sex: All, ages: 75 Years to any

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

Participant flow

Outcome results

• Any Incidence of Hypoglycemia (Primary), Count of participants, Participants: Educational Video and Action Plan Handout 101; Usual Care 109
• Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia (Secondary)
• Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia (Secondary)
• Patient-Reported Outcome: Problem Areas in Diabetes (Secondary)
• Clinical Utilization Outcome: Hypoglycemic-related Admissions to Emergency Department or Hospital (Secondary)
• Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire (Secondary)
• Patient-Centered Outcome: Perceived Efficacy in Patient - Physician Interactions (Secondary)
• Patient-Centered Outcome: Active Patient Participation During Primary Care Visits (Secondary)
• Medication-Related Outcome: Aggregate Measure of Diabetes Medication Deprescribing (Secondary)

Adverse events

Time frame: From enrollment to end of follow-up, up to 12 months

• Results publication: 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. PMID 40222399

• Study Protocol and Statistical Analysis Plan (PDF, 2020-12-08)

• Richard W Grant, MD MPH, Principal investigator, Kaiser Permanente Northern California - Division of Research

NIH grants: R01AG068133