ACTIVE_NOT_RECRUITING

Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.

Official Title

Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

Quick Facts

Study Start:2024-05-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06465693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Have a previous diagnosis of type 2 diabetes
  3. * HbA1c of 7.0 - 9.5%
  4. * Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.
  1. * Type 1 diabetes
  2. * Treatment with insulin, sulfonylurea, or meglitinide
  3. * Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
  4. * BMI \<25 kg/m2
  5. * Weight change \&gt;5 pounds in the 3 months prior to enrollment
  6. * Estimated glomerular filtration rate \&lt;60 ml/minute/1.73 m2
  7. * Pregnant or breastfeeding
  8. * Anemia (which affects HbA1c)
  9. * Presence of any disease that would make adherence to the protocol difficult

Contacts and Locations

Principal Investigator

Anne Bantle, MD,MS
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Anne Bantle, MD,MS, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes