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Proactive Non-Physician Outreach for Type 2 Diabetes

N/A
Waitlist Available
Led By Lisa Gilliam, MD, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Kaiser Permanente Northern California (KPNC) member age 18-74
Incident Type 2 Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is looking at whether or not proactive outreach by a non-physician clinician to patients with newly diagnosed Type 2 diabetes can help them better manage their disease.

Who is the study for?
This trial is for adults aged 18-74 who are members of Kaiser Permanente Northern California, have recently been diagnosed with Type 2 Diabetes, and haven't started on metformin despite having an A1c level between 6.5-7.9%. Pregnant individuals or those likely to have Type 1 diabetes, or a previous diagnosis of T2D are excluded.Check my eligibility
What is being tested?
The study tests if proactive outreach by non-physician clinicians (Accountable Population Managers) can help patients newly diagnosed with Type 2 Diabetes start treatment early and reach blood sugar targets within six months.See study design
What are the potential side effects?
Since the interventions involve education and outreach rather than medications, there may not be direct side effects like those associated with drugs; however, participants might experience stress or anxiety from increased engagement about their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 74 years old and a member of Kaiser Permanente Northern California.
Select...
I have been diagnosed with Type 2 Diabetes recently.
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My diabetes treatment with metformin hasn't changed despite needing adjustment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c<7%
HbA1c<8%
HbA1c<9%
Secondary outcome measures
Absolute mean reduction in HbA1c from baseline
Adherence to HbA1c monitoring
Emergency room visits and hospitalizations post-intervention start
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3: Physician Education + Accountable Population Manager OutreachExperimental Treatment2 Interventions
Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia. Patients enrolled in this arm may receive proactive outreach from an Accountable Population Manager (APM).
Group II: Arm 2: Physician EducationExperimental Treatment1 Intervention
Physicians in service areas randomized to this arm were invited to a physician education session on therapeutic inertia.
Group III: Arm 1: Usual CareActive Control1 Intervention
Participants will receive standard care for newly diagnosed Type 2 Diabetes.

Find a Location

Who is running the clinical trial?

American Diabetes AssociationOTHER
141 Previous Clinical Trials
98,994 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
541 Previous Clinical Trials
23,906,299 Total Patients Enrolled
Lisa Gilliam, MD, PhDPrincipal InvestigatorKaiser Permanente

Media Library

Accountable Population Manager outreach Clinical Trial Eligibility Overview. Trial Name: NCT05566847 — N/A
Type 2 Diabetes Clinical Trial 2023: Accountable Population Manager outreach Highlights & Side Effects. Trial Name: NCT05566847 — N/A
Accountable Population Manager outreach 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566847 — N/A
Type 2 Diabetes Research Study Groups: Arm 1: Usual Care, Arm 2: Physician Education, Arm 3: Physician Education + Accountable Population Manager Outreach
~182 spots leftby Dec 2024
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