Diabetes Medical Nutrition Therapy for type 2 diabetes in a large health system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm pilot randomized implementation trial conducted within Kaiser Permanente Southern California to test the delivery of a Diabetes Medical Nutrition Therapy (DM MNT) program for adults with type 2 diabetes and A1c 8–13%. Approximately 600 participants will be randomized 1:1 to receive DM MNT or standard care. The study will measure implementation outcomes using the RE-AIM framework and assess effects on glycemic control and other clinical outcomes to inform broader integration into routine diabetes care. The setting focuses on the San Bernardino Regional Area within the KPSC network to evaluate feasibility and potential impact in routine practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Kaiser Permanente Southern California member
* Type 2 diabetes diagnosis (ICD-10 codes E11. (all subcodes for type 2 diabetes))
* Ages 18-75 (Age calculated as of the date the eligibility list is generated. Include patients whose age is ≥18 and ≤75 on that date)
* Glycated hemoglobin (A1c) between 8-13 (Most recent hemoglobin A1c value within the past 6 months is ≥8% and ≤13% as of the date the eligibility list is generated)
* Actively seeing a care manager (Have an upcoming appointment with a Care Manager)

Exclusion Criteria:

* Kidney disease stage 4-5 (ICD-10 codes: N18.4 (CKD stage 4), N18.5 (CKD stage 5) within last 6 months)
* Current dialysis (Procedure codes: CPT 90935, 90937, 90945, 90947, 90999; OR encounter with dialysis service in last 6 months)
* Active cancer treatment (ICD-10 codes for cancer (C00-C97) combined with recent treatment (chemotherapy, radiation, immunotherapy) within last 6 months)
* Pregnancy (ICD-10 codes O00-O9A, positive pregnancy test labs, or encounters with OB/GYN codes indicating pregnancy in last 9 months)
* Diagnosed eating disorders (ICD-10 codes: F50.\* (all eating disorder subcodes). within past 36 months)
* Currently in palliative care/hospice (Encounter type or service codes for hospice or palliative care in the past 6 months)
* Currently receiving Nutrition Support (Orders for enteral or parenteral nutrition (EN/PN) or dietitian notes indicating ongoing nutrition support in the past 6 months: ID codes: 670795, 520142, 525183, 534927)

Where it's running

• Kaiser Permanente San Bernardino County Medical Center
  Fontana, California, United States Recruiting

Study contacts

• Study coordinator: Taynara Formagini, PhD
• Email: Taynara.X.Formagini@kp.org
• Phone: 626-564-3427

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.