Type 2 Diabetes Trial, Recruiting NCT07361341 Sponsor: Wake Forest University Health Sciences Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Recruiting

NCT07361341
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older at the time of their first clinic visit during the study period, regardless of sex, gender, race, or ethnicity
  • People who are active patients at the Community Care Clinic (CCC) and had at least one clinic visit between January 1, 2024 and December 31, 2024, with at least one follow-up appointment scheduled during the study period
  • People who meet CCC's standard patient criteria: no health insurance, a household income at or below 250% of the Federal Poverty Level, and living in Forsyth County, North Carolina or the surrounding service area
  • People who completed at least one food insecurity screening (a standard questionnaire about access to food) during the study period as part of their regular care at CCC
  • People whose medical records include at least one recorded measurement for body weight/BMI, blood pressure, blood sugar level (HbA1c), or healthcare visits
  • People diagnosed with Type 2 diabetes, OR people diagnosed with pre-diabetes who have a blood sugar (HbA1c) level of 9.5% or higher
  • People living within the designated areas for food package pickup or delivery, primarily in zip codes 27101, 27105, 27107, and nearby areas
  • People who are able and willing to sign a written consent form, available in English or Spanish
  • People who are able to take part in study check-ins and assessments in either English or Spanish

Who may not be able to join:

  • People who are not able to communicate proficiently in English or Spanish, as the study and CCC staff are only set up to provide services in those two languages
  • People with known food allergies (recorded in their medical file or reported to clinic or study staff) that could prevent them from safely taking part in the food bundle program
  • People whose medical records are missing key personal details such as age or gender that cannot be confirmed through other sources
  • People who were pregnant at any point during the study period, as pregnancy causes natural changes in weight, blood pressure, and blood sugar that could affect the results
  • People who received a terminal illness diagnosis or were receiving hospice care during the study period
  • People who only visited CCC once for urgent or emergency care, without an ongoing care relationship at the clinic (defined as fewer than 2 visits during the study period)
  • People with a Type 1 diabetes diagnosis, end-stage kidney disease requiring dialysis, an active eating disorder, severe food allergies that would prevent safely eating the food bundles, or who had bariatric (weight loss) surgery within the past 12 months
  • People with a documented cognitive impairment or intellectual disability that would affect their ability to give informed consent or take part meaningfully in the program without support from a caregiver
  • People currently enrolled in other intensive nutrition programs or food prescription studies that could interfere with measuring this study's results independently
  • People who plan to move out of CCC's service area or stop receiving care at CCC within the 6-month study period
  • People who have physical disabilities, difficulty with reading, or other factors that would prevent them from completing the study surveys, unless reasonable adjustments can be made

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Megan B Irby, PhD, Wake Forest University Health Sciences

Phone: 336.758.4642

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hemoglobin A1c; Hemoglobin A1c; Hemoglobin A1c; Self-efficacy in diabetes management; Self-efficacy in diabetes management; Self-efficacy in diabetes management

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov