Recruiting

DM MNT

Sponsor:

Kaiser Permanente

Code:

NCT07868250

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Diabetes Medical Nutrition Therapy (DM MNT) Pilot

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT07868250

Start date

Jun 17, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention: Diabetes Medical Nutrition Therapy (DM MNT) Pilot

no intervention: Control: Standard Care

Interventions

Diabetes Medical Nutrition Therapy (DM MNT) Pilot

DM MNT intervention is a targeted clinical initiative designed to improve glycemic control and overall health outcomes for adults with poorly controlled diabetes (HgbA1c ≥ 8%) in San Bernardino County. The program leverages evidence based Medical Nutrition Therapy (MNT) provided by Registered Dietitians (RDs) as a primary intervention, emphasizing personalized care, behavior change support, and coordinated management with clinical teams.

Primary outcome measure

  • Mean Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to 12 months. ]

Central Contacts and Locations

Central contacts

Taynara Formagini, PhD

626-564-3427Taynara.X.Formagini@kp.org

Locations

Kaiser Permanente San Bernardino County Medical Center

Recruiting

Fontana, California, United States, 92335

Contacts

Valerie T Steve, MPH

855-266-4560Valerie.T.Steve@kp.org

Angela Shumaker, MPH, RDN

855-266-4560Angela.O.Shumaker@kp.org

Principal Investigator:

Taynara Formagini, PhD, MSc

More Information

Sponsor

Kaiser Permanente

Last update posted

Oct 9, 2026

Last verified

Sep, 2026

Keywords

  • nutrition therapy
  • medical nutrition therapy
  • diabetes mellitus, type 2
  • type 2 diabetes
  • diabetes management
  • diabetes control intervention
  • glycemic control
  • glycemic control intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.