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

NCT06906653 | Enrolling By Invitation

• 1 other identifier: 2220224
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Average hemoglobin A1c (HbA1c)

  Between-arm differences in HbA1c

  6-months

• Average hemoglobin A1c (HbA1c)

  Between-arm differences in HbA1c

  12-months

Secondary Outcomes (10)

• Time to achievement of glycemic targets

  6-months

• Time to achievement of glycemic targets

  12-months

• Adherence to HbA1c monitoring

  6-months

• Adherence to HbA1c monitoring

  12-months

• Type 2 diabetes medication and statin initiation

  6-months

Study Arms (2)

Usual Initial Type 2 Diabetes (T2D) Care

NO INTERVENTION

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.

Augmented Initial Type 2 Diabetes (T2D) Care

EXPERIMENTAL

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

Interventions

Augmented Initial Type 2 Diabetes Care BEHAVIORAL

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.

Augmented Initial Type 2 Diabetes (T2D) Care

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• The Permanente Medical Group: collaborator

Study Sites (1)

Kaiser Permanente Division of Research

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)