| NCT ID | NCT07868250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaiser Permanente |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2026-06-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07868250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07868250 currently recruiting?
Yes, NCT07868250 is actively recruiting participants. Contact the research team at Taynara.X.Formagini@kp.org for enrollment information.
Where is the NCT07868250 trial being conducted?
This trial is being conducted at Fontana, United States.
Who is sponsoring the NCT07868250 clinical trial?
NCT07868250 is sponsored by Kaiser Permanente. The trial plans to enroll 600 participants.
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