None listed
Conditions
Interventions
None listed
Sponsors
Ultrahuman Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: General inclusion criteria for healthy and prediabetic population: Subjects within the age group of 25-50 years. Subjects willing to participate in the study. BMI within 20 â?? 30 kg per m2 Willing to comply to the advised use of CGM, activity tracker, CGM reader and the UH Application. Inclusion criteria for healthy population: Fasting blood glucose level at screening 79-99 mg/dl HbA1c range 4.0-5.6 percentage 2-hour plasma glucose during 75-g OGTT below 140 mg/dL (less than 7.8 mmol/L) Inclusion criteria for prediabetic population: Fasting blood glucose level at screening 100-125 mg/dl OR HbA1c range 5.7-6.4 percentage OR 2-hour plasma glucose during 75-g OGTT 140â??199 mg/dL (7.8â??11.0 mmol/L)
Exclusion criteria
Exclusion criteria: History of acute or subacute infection in the last three months. History of chronic illnesses and autoimmune conditions. Subjects on antimicrobial drug agents, including antibiotics, antivirals, or antifungals Subjects pre-diagnosed with Type 1 Diabetes Subjects pre-diagnosed with Type 2 Diabetes Mellitus according to the ADA (American Diabetes Association) criteria. Subjects with anemia [less than male 13 grams per dL and females less than 12 grams per dL] Documented known medical history of any impaired renal and liver function. Subjects diagnosed with cardiac disease, including angina, heart failure, arrhythmias, valvular heart disease, or congenital heart disease. Subjects with regular alcohol consumption of more than eight drinks per week and 15 drinks per week in women and men, respectively. Enrolment in any kind of weight reduction program in the last six months Unexplained intentional or unintentional weight loss of more than 10 percent of average weight in the previous six months Subjects currently on diet plans such as keto, low carb and intermittent fasting. Pregnant and lactating females Out of range results in any of the screening tests carried out for blood glucose measurements (FBG, HbA1c and OGTT tests)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGM-based glucose indices over 14 days of period Mean glucose levels described by a 24-hour profile during 2 weeks Time in glucose ranges Glycaemic variability as measured by the standard deviation, coefficient of variation, MAGETimepoint: Day 1 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FBS from day 0 to day 15 Assessing the correlations between the biomarkers and metabolic health metrics, the key relationships to explore are: Glucose variability indices and sleep duration Glucose variability indices and stress (as measured by cortisol) Glucose variability indices and inflammation (as measured by Hs-CRP) Glucose variability indices and gut microbiome index Glucose variability indices and urine metabolites Glucose variability indices and physical activity (limited to step count and heart rate)Timepoint: Day 0 and Day 14 | — |
Countries
India
Contacts
Public ContactSuresh Kumar Karri
Triomics Healthcare Pvt Ltd
Outcome results
None listed