None listed
Conditions
Interventions
Intervention1: Twins Precision Treatment: TPT includes Blood data, sensor data collection, artificial intelligence, digital twin, mobile app, remote coaching for nutrition and excercise
Frequency 90d
Sponsors
Twins Digital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women between ages 18 and 70 2. Diabetes duration of � 8 years 3. Own smartphone and capable of using for TPT 4. Type 2 Diabetes: HbA1c > 6.4 with or without anti-diabetic therapy OR on anti-diabetic therapy with any HbA1c 5. Adequate Hepatic Function: AST/ALT � 3.0 x ULN 6. Adequate Renal Function defined by eGFR > 60 mL/min/1.73 m2 7. BMI: � 23 Kg/m2
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity onset diabetes of the young (MODY), pancreatic diabetes, gestational diabetes mellitus, or any secondary diabetes by clinical history 2. History of keto-acidosis 3. History of myocardial infarction, stroke, angina within the last 3 months 4. Need for current chronic corticosteroid therapy (� 2.5 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids) 5. Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) 6. Major surgical procedure or significant traumatic injury within 28 days prior to Enrollment Date 7. Patients who have undergone or are planning for any bariatric procedure 8. Pregnant and lactating females 9. Any medical or surgical condition that the principal investigator considers to make the patient unfit for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the change in HbA1c at 90-day intervals from baseline between the intervention group and the usual care group 2. To compare dosage reductions and eliminations in insulin and oral anti-diabetic medications at 90-day intervals from baseline between the intervention and usual care groups 3. To assess the incidence, progression and regression of microvascular complications between the intervention and usual care groups Timepoint: 90 days intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare partial, complete and prolonged remission of type 2 diabetes using the TPT versus usual care. 2. To compare weight, BMI and waist circumference at 90-day intervals between intervention and usual care groupsTimepoint: 90 days intervals | — |
Countries
India, United States of America
Contacts
Public ContactDr Paramesh S
Bangalore Diabetes Centre
Outcome results
None listed