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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes (T2D)
• Intervention / Treatment: Behavioral: Augmented Initial Type 2 Diabetes Care

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Kaiser Permanente Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Initial Type 2 Diabetes (T2D) Care; Patients in the usual care arm will receive the standard T2D care provided to Kaiser Permanente Northern California members with recently diagnosed T2D. This care includes any counseling or treatment recommendations made by the primary care provider and the assigned care manager.
Experimental: Augmented Initial Type 2 Diabetes (T2D) Care; The intervention - Augmented Initial T2D Care - comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team and self-management support by care managers, health educators, and dieticians.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average hemoglobin A1c (HbA1c)	Between-arm differences in HbA1c	6-months
Average hemoglobin A1c (HbA1c)	Between-arm differences in HbA1c	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achievement of glycemic targets		6-months
Time to achievement of glycemic targets		12-months
Adherence to HbA1c monitoring	Number of participants with a new HbA1c laboratory value	6-months
Adherence to HbA1c monitoring	Number of participants with a new HbA1c laboratory value	12-months
Type 2 diabetes medication and statin initiation	Number of participants who are prescribed a type 2 diabetes medication and/or statin	6-months
Type 2 diabetes medication and statin initiation	Number of participants who are prescribed a type 2 diabetes medication and/or statin	12-months
Type 2 diabetes medication adherence	Proportion of days covered since initiation	6-months
Type 2 diabetes medication adherence	Proportion of days covered since initiation	12-months
Completion of preventative screening	Number of participants who complete retinal and microalbuminuria screening	6-months
Completion of preventative screening	Number of participants who complete retinal and microalbuminuria screening	12-months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: The Permanente Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2220224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No