Sansum Clinic, Sutter Health
Santa Barbara, California, 93110, United States
Location status: Recruiting
NCT Number: NCT06999356
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Santa Barbara, California, 93110, United States
Location status: Recruiting
The aim of this proposal is to determine the impact of a produce prescription program in predominantly Hispanic/Latino adults with established non-insulin treated T2D and an HbA1c at or above 9%. For individuals not responding to the produce prescription program, they will be randomized to the addition of real-time continuous glucose monitoring (rtCGM) or continue with the produce prescription program only for a further 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults (aged>18 years) with established T2D and HbA1c of 9% or higher per most recent test result within the last 6 months.
Agreement to only track glucose levels via study-provided CGM -
Exclusion criteria
Type 1 diabetes, Insulin use, Pregnancy, Use of steroids or medications that impact glucose levels
Medications Include:
Atypical antipsychotics Clozapine Olanzapine Paliperidone Quietiapine Risperidone Corticosteroids Calcineurin inhibitors Cyclosporine Sirolimus Tacrolimus Protease Inhibitors Atazanavir Darunavir Fosamprenavir Indinavir Nelfinavir Ritonivir Saquinavir Tipranivir
Life expectancy less than 6 months Diagnosis of stage 5 kidney disease or at risk of needing dialysis per Investigator discretion Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
Inability to follow study procedures per Investigator discretion
-
Fruits and Vegetables and some groups will get CGM devices along with Fruits and Vegetables
Time frame: 18 weeks
Change in HbA1c at 18 weeks compared to baseline
Time frame: 6 weeks and 3 months
Weight will be measured in kg.
Time frame: 6 weeks and 3 months
Waist Circumference will be measure in cm
Time frame: 6 weeks and 3 months
Blood pressure will be measure in mm Hg.
Time frame: 6 weeks and 3 months
For the scales, the DASS-21 (Depression Anxiety Stress Scale - 21) reports on depression, anxiety, and stress by using a self-report questionnaire with 21 items. It consists of three subscales, each with seven items, assessing the frequency and severity of symptoms related to each emotion.
The questionnaire uses a Likert scale (0-3) where higher scores indicate greater symptom severity.
Scoring: Each subscale (Depression, Anxiety, and Stress) is scored separately by summing the responses to its respective items. The total score for each subscale can range from 0 to 21.
Interpretation: Higher scores on each subscale indicate a higher level of the corresponding variable.
Time frame: 6 weeks and 3 months.
Height will be measure in inches.
Contact information is provided by the study sponsor or research team.
Brett Avery
CONTACT
David Kerr, PhD
CONTACT
Sutter Health
Other
Salud Diabetes: A Pilot Study Comparing Lifestyle Interventions and Real-Time Continuous Glucose Monitoring In Predominantly Hispanic/Latino Adults With Non-Insulin Treated Type 2 Diabetes And An HbA1c > 9%
Acronym: Salud Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05912647
Diabetes, Diabetes Mellitus
Madison, Wisconsin, United States
View Trial DetailsNCT07617519
Autoimmune Diseases, Diabetes
Herlev, Denmark
View Trial DetailsNCT07272837
Body Weight, Diabetes
Edmonton, Alberta, Canada
View Trial DetailsNCT06138821
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial Details