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Advance Care Planning for Type 2 Diabetes

N/A

Recruiting

Led By Richard W Grant, MD MPH

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 75 years

Type 2 diabetes with last measured HbA1c ≤ 8.0%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 - 12 months following the first study-related visit

Awards & highlights

Study Summary

This trial looks at whether expanded advance care planning can help older adults with type 2 diabetes make treatment decisions that are aligned with their values, and whether this can reduce the incidence of hypoglycemia.

Who is the study for?

This trial is for people aged 75 or older with Type 2 diabetes, who have an HbA1c level of 8.0% or less and are taking insulin or sulfonylureas (SUs). Participants must be Kaiser Permanente Northern California members, able to give informed consent, make decisions about their care, and communicate in English.Check my eligibility

What is being tested?

The study is testing a web-based educational program called 'Prepare for Your Diabetes Care' against usual care. It aims to help older adults align their diabetes treatment with personal values by reassessing their treatment plans with healthcare teams to reduce the risk of low blood sugar complications.See study design

What are the potential side effects?

Since this intervention involves education and planning rather than medication, direct side effects are not expected. However, changes in diabetes management as a result could lead to adjustments in blood sugar levels that need monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 75 years old or older.

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My last HbA1c level was 8.0% or lower and I have type 2 diabetes.

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I am currently taking insulin or sulfonylureas for my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 - 12 months following the first study-related visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 - 12 months following the first study-related visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 12 months following the first study-related visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Any incidence of hypoglycemia

Secondary outcome measures

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

Medication-Related Outcome: Aggregate measure of diabetes medication deprescribing

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

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Educational Video and Action Plan handoutExperimental Treatment1 Intervention

Patients 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.

Group II: Usual CareActive Control1 Intervention

Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,493 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,325 Total Patients Enrolled

Richard W Grant, MD MPHPrincipal InvestigatorKaiser Permanente Northern California - Division of Research

6 Previous Clinical Trials

2,443 Total Patients Enrolled

Media Library

Prepare for Your Diabetes Care Clinical Trial Eligibility Overview. Trial Name: NCT05263310 — N/A

Type 2 Diabetes Research Study Groups: Usual Care, Educational Video and Action Plan handout

Type 2 Diabetes Clinical Trial 2023: Prepare for Your Diabetes Care Highlights & Side Effects. Trial Name: NCT05263310 — N/A

Prepare for Your Diabetes Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263310 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this experiment?

"Affirmative. Per the clinicaltrials.gov, this research endeavour is currently open to applicants since it was initially posted on April 25th 2022 and recently updated on May 3rd of that same year. The study seeks 600 participants from a single medical centre."

Answered by AI

Are there any open slots for enrollment in this experiment?

"Data found on clinicaltrials.gov affirms that this experiment is open to applicants and actively seeking participants, with the listing having first been posted in April of 2022 before its most recent update being issued in May."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prepare for Your Diabetes Care

2022. "Prepare for Your Diabetes Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05263310.

All > Hypoglycemia