Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
Launched by KAISER PERMANENTE · Apr 1, 2025
Trial Information
Current as of November 10, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study tests whether an “augmented” initial care plan helps people with newly diagnosed Type 2 diabetes manage their blood sugar better than usual care. It’s a randomized trial conducted with Kaiser Permanente Northern California. Eligible adults are 18–74 years old who have just been diagnosed with Type 2 diabetes and have higher-than-average blood sugar at diagnosis (HbA1c is the blood test used to measure this; it looks at average blood sugar over the past 2–3 months). The exact HbA1c threshold depends on age: if you are 45 or younger, you need an HbA1c above 8%; if you are younger than 45, the threshold is above 10%. Pregnant people or those likely to have Type 1 diabetes are not eligible.
Participants are randomly assigned to two groups: Usual Initial Type 2 Diabetes Care or Augmented Initial Type 2 Diabetes Care. The augmented plan adds more proactive outreach by the diabetes care team and extra support for self-management from care managers, health educators, and dietitians. It includes four components: notifying your primary care doctor that you’ve been chosen for augmented care, early outreach by a care manager to help set up care and prescriptions, a one-on-one virtual visit with a health educator to reinforce self-management and set up glucose monitoring if eligible, and a one-on-one virtual nutrition visit. The study uses electronic health record data to compare outcomes at 6 and 12 months, focusing on average HbA1c and other measures such as time to reach glycemic targets, starting or sticking with diabetes medicines or statins, and completing routine eye and kidney screenings. The trial is currently enrolling by invitation and is expected to finish around 2027.
Gender
ALL
Eligibility criteria
- 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)
About Kaiser Permanente
Kaiser Permanente is a leading integrated health care organization that combines a health plan with a network of hospitals and physicians to provide comprehensive medical services. With a strong commitment to advancing medical research and improving patient care, Kaiser Permanente sponsors clinical trials across various therapeutic areas. The organization emphasizes innovative approaches to health care, leveraging its extensive data and resources to support evidence-based treatments and enhance patient outcomes. Through its rigorous research initiatives, Kaiser Permanente aims to contribute to the advancement of medical knowledge and the development of new therapies that benefit diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pleasanton, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported