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

Not Applicable

• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes (T2D)

• Registration Number: NCT06906653
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Age 18-74 years
• Newly diagnosed with type 2 diabetes
• Kaiser Permanente Northern California member receiving care in a participating service area
• If age ≤45 years, then HbA1c>8%
• If age<45 years, then HbA1c>10%

Exclusion Criteria

• Individuals who are pregnant
• Individuals with likely type 1 diabetes (T1D)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average hemoglobin A1c (HbA1c)	12-months	Between-arm differences in HbA1c

Secondary Outcome Measures

Name	Time	Method
Time to achievement of glycemic targets	12-months
Adherence to HbA1c monitoring	12-months	Number of participants with a new HbA1c laboratory value
Type 2 diabetes medication and statin initiation	12-months	Number of participants who are prescribed a type 2 diabetes medication and/or statin
Type 2 diabetes medication adherence	12-months	Proportion of days covered since initiation
Completion of preventative screening	12-months	Number of participants who complete retinal and microalbuminuria screening

Trial Locations

Locations (1)

Kaiser Permanente Division of Research; 🇺🇸 Pleasanton, California, United States