Clinical trial NCT06465693: Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
Official title: Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: HgbA1c
timeFrame: week 12
Secondary outcomes:
measure: Glucose variability/coefficient of variation
timeFrame: week 12
measure: mean glucose
timeFrame: week 12
measure: time in range (glucose 70-180 mg/dl)
timeFrame: week 12
measure: time above range (glucose 70-180 mg/dl)
timeFrame: week 12
measure: Weight
timeFrame: week 12
measure: Fasting plasma glucose
timeFrame: week 12
measure: Fasting serum insulin
timeFrame: week 12
measure: Serum lipid panel
timeFrame: week 12
measure: Intervention Acceptability Questionnaire
timeFrame: week 12
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: week 12
measure: Diet Satisfaction Questionnaire (DSat-28)
timeFrame: week 12
measure: Diabetes Management Self-Efficacy Scale (DMSES)
timeFrame: week 12
measure: Medication Effect Score
timeFrame: week 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne Bantle, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: