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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465693
• Other study ID #: MED-2023-32168
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Anne Bantle, MD, MS
• Phone: 612-625-8673
• Email: bant0015[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 >5 pounds in the 3 months prior to enrollment
• Estimated glomerular filtration rate <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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Unblinded CGM plus nutrition therapy
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

Behavioral:
• Nutrition therapy only
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HgbA1c		week 12
Secondary	Glucose variability/coefficient of variation	using CGM data	week 12
Secondary	mean glucose	using CGM data	week 12
Secondary	time in range (glucose 70-180 mg/dl)	using CGM data	week 12
Secondary	time above range (glucose 70-180 mg/dl)	using CGM data	week 12
Secondary	Weight		week 12
Secondary	Fasting plasma glucose		week 12
Secondary	Fasting serum insulin		week 12
Secondary	Serum lipid panel		week 12
Secondary	Intervention Acceptability Questionnaire		week 12
Secondary	Diabetes Treatment Satisfaction Questionnaire (DTSQ)		week 12
Secondary	Diet Satisfaction Questionnaire (DSat-28)		week 12
Secondary	Diabetes Management Self-Efficacy Scale (DMSES)		week 12
Secondary	Medication Effect Score		week 12