Type 2 Diabetes Clinical Trial
— DiaTeleMedOfficial title:
Personalized Dietary Management in Type 2 Diabetes
In a randomized trial of 255 participants with early-stage T2D, participants will be randomized with equal allocation (n=85 each) to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC).
Status | Recruiting |
Enrollment | 255 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: - must be an adult 21-80 years of age - must be diagnosed with early-stage T2D defined as HbA1c<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin. - those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions Exclusion Criteria: - those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study - those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring - those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy. - those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study - those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism) - those who require special dietary management (end-stage kidney disease, cirrhosis, HIV) - those who are unable or unwilling to provide informed consent - those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia) - those who are unwilling to accept randomization assignment - those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated) - those who have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months - those who are unable to walk without a walker or cane for 2 city blocks - those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years - those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease) - those who have an active substance use disorder |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Amplitude of Glycemic Excursion (MAGE) | MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm. | Month 3 | |
Primary | Mean Amplitude of Glycemic Excursion (MAGE) | MAGE will be evaluated via a continuous glucose monitor (CGM), which captures interstitial glucose readings every 15 minutes for up to 2 weeks from a sensor inserted into the participant's upper arm. | Month 6 | |
Secondary | HbA1c Levels | Glycosylated hemoglobin will be evaluated from blood sampling (~10 ml) obtained during CTRC measurement visits, evaluated in the NYU CLIA-certified lab. | Month 3 | |
Secondary | HbA1c Levels | Glycosylated hemoglobin will be evaluated from blood sampling (~10 ml) obtained during CTRC measurement visits, evaluated in the NYU CLIA-certified lab. | Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |