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KPSC MNT Pilot RCT

RecruitingNAAges 18 Years - 75 YearsAllKaiser Permanente
NCT07868250 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this pilot randomized trial is to evaluate the implementation and effectiveness of a Diabetes Medical Nutrition Therapy (DM MNT) program for adults with type 2 diabetes and poor glycemic control receiving care in a large integrated health system. The study will assess implementation outcomes using the RE-AIM framework, as well as changes in glycemic control and other clinical outcomes, to inform potential broader implementation of MNT within routine diabetes care.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Diabetes Medical Nutrition Therapy (DM MNT) Pilot
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Where

1 site
Kaiser Permanente San Bernardino County Medical Center
Fontana, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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