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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy |
|
| Group 2 | Active Comparator | After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HgbA1c | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose variability/coefficient of variation | using CGM data | week 12 |
| mean glucose | using CGM data | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Bantle, MD,MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes
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| 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. |
|
| time in range (glucose 70-180 mg/dl) | using CGM data | week 12 |
| time above range (glucose 70-180 mg/dl) | using CGM data | week 12 |
| Weight | week 12 |
| Fasting plasma glucose | week 12 |
| Fasting serum insulin | week 12 |
| Serum lipid panel | week 12 |
| 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 |
| D004700 | Endocrine System Diseases |