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Active, Not Recruiting

NCT Number: NCT06465693

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Have a previous diagnosis of type 2 diabetes
  • HbA1c of 7.0 - 9.5%
  • Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.

Exclusion criteria

  • Type 1 diabetes
  • Treatment with insulin, sulfonylurea, or meglitinide
  • Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
  • BMI <25 kg/m2
  • Weight change &gt;5 pounds in the 3 months prior to enrollment
  • Estimated glomerular filtration rate &lt;60 ml/minute/1.73 m2
  • Pregnant or breastfeeding
  • Anemia (which affects HbA1c)
  • Presence of any disease that would make adherence to the protocol difficult

Treatment and study plan

Unblinded CGM plus nutrition therapy

Device

will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.

will receive Dexcom G6 Pro CGMs to wear throughout the study. The CGM will be unblinded so that the glucose data will be available in real time to the participant and investigators. The dietitian and participant will review CGM data together

Nutrition therapy only

Behavioral

will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.

Primary outcomes

  1. HgbA1c

    Time frame: week 12

Secondary outcomes

  1. Glucose variability/coefficient of variation

    Time frame: week 12

    using CGM data

  2. mean glucose

    Time frame: week 12

    using CGM data

  3. time in range (glucose 70-180 mg/dl)

    Time frame: week 12

    using CGM data

  4. time above range (glucose 70-180 mg/dl)

    Time frame: week 12

    using CGM data

  5. Weight

    Time frame: week 12

  6. Fasting plasma glucose

    Time frame: week 12

  7. Fasting serum insulin

    Time frame: week 12

  8. Serum lipid panel

    Time frame: week 12

  9. Intervention Acceptability Questionnaire

    Time frame: week 12

  10. Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: week 12

  11. Diet Satisfaction Questionnaire (DSat-28)

    Time frame: week 12

  12. Diabetes Management Self-Efficacy Scale (DMSES)

    Time frame: week 12

  13. Medication Effect Score

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Jul 28, 2025

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.

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