Prepare for Your Diabetes Care (NCT05263310) | Clinical Trial Compass
CompletedNot Applicable
Prepare for Your Diabetes Care
United States669 participantsStarted 2022-04-25
Plain-language 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 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on hypoglycemia in older adults with Type 2 diabetes — given my own history with low blood sugar episodes, is this something my care team is actively monitoring in my current treatment plan?
2Since the trial has already been completed, would my doctor be able to share or look up any published findings about whether the 'Prepare for Your Diabetes Care' program actually reduced hypoglycemia incidents in participants?
3The trial seems to involve patient activation, meaning helping patients become more engaged in their own care — are there similar programs or tools my doctor could recommend that I could use right now without being in a study?
4Because this was a Phase NA study focused on education or behavioral support rather than a new drug, does my doctor think this kind of approach could complement my existing diabetes medication plan rather than replace anything I'm currently doing?
5If I'm at risk for hypoglycemia, what warning signs and self-management steps should I already know about, and does my doctor think a structured program like this one could help me feel more prepared between appointments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.