NCT06906653

Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.

Conditions

• Type 2 Diabetes
• Type 2 Diabetes Mellitus (T2DM)
• Type 2 Diabetes (T2D)

Interventions

Type	Name	Description
BEHAVIORAL	Augmented Initial Type 2 Diabetes Care	The intervention will include 4 components: 1) Making primary care providers (PCPs) aware that the patient has been selected to receive "Augmented Initial Type 2 Diabetes (T2D) Care", 2) encouraging early care manager outreach to establish care, ensure prescribing of appropriate medications, and support medication adherence, 3) a one-on-one virtual health educator visit to reinforce self-management education and ensure set-up of remote glucose monitoring or continuous glucose monitoring (if eligible), and 4) a one-on-one virtual nutrition visit to provide individualized counseling.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States