Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Nutrition, CGM
Brief summary
This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).
Interventions
BEHAVIORALUnblinded CGM/Nutrition Therapy
Personalized nutrition counseling based on CGM data
BEHAVIORALBlinded CGM/Nutrition Therapy
Standard nutrition education which does not incorporate CGM data
BEHAVIORALUnblinded CGM/No Nutrition Therapy
CGM and general diabetes education (no nutrition education)
BEHAVIORALBlinded CGM/No Nutrition Therapy
General diabetes education (no nutrition education)
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Randomized Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * previous diagnosis of T2DM * HbA1c of 6.8-8.5%
Exclusion criteria
* type 1 diabetes mellitus * treatment with insulin, sulfonylurea, or meglitinide * use of nondiabetic medications that affect blood glucose control (such as corticosteroids) * BMI \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as Asian * weight change \>5 pounds in the 3 months prior to study enrollment * estimated glomerular filtration rate \<60 ml/minute/1.73 m2 * pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 weeks | Measure of blood glucose control |
Countries
United States
Contacts
CONTACTAnne Bantle
PRINCIPAL_INVESTIGATORAnne Bantle
University of Minnesota
Outcome results
None listed