Type 2 Diabetes
Conditions
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.
Interventions
DEVICEUnblinded 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
BEHAVIORALNutrition 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HgbA1c | week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean glucose | week 12 | using CGM data |
| time in range (glucose 70-180 mg/dl) | week 12 | using CGM data |
| time above range (glucose 70-180 mg/dl) | week 12 | using CGM data |
| Weight | week 12 | — |
| Fasting plasma glucose | week 12 | — |
| Fasting serum insulin | week 12 | — |
| Glucose variability/coefficient of variation | week 12 | using CGM data |
| Intervention Acceptability Questionnaire | week 12 | — |
| Diabetes Treatment Satisfaction Questionnaire (DTSQ) | week 12 | — |
| Diet Satisfaction Questionnaire (DSat-28) | week 12 | — |
| Diabetes Management Self-Efficacy Scale (DMSES) | week 12 | — |
| Medication Effect Score | week 12 | — |
| Serum lipid panel | week 12 | — |
Countries
United States
Outcome results
None listed