Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Celevida DiaFiber : Formulation: Sachets containing soluble dietary fiber.
Dosage and Administration: 1 sachet orally, dissolved in water, taken 5 10
minutes before each of two major me
Sponsors
Dr. Reddys and Nestl Health Science Limited (DNHS)
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion: Adults 35 60 years with T2DM more than 1 year, HbA1c more than 8.5%, PPG more than 250 mg/dL, BMI more than25 kg/m (Asian cut-off), stable on oral hypoglycemic agents more than 3 months, able to consent and comply, and with access to a smartphone or CGM reader.
Exclusion criteria
Exclusion criteria: Key exclusion: Type 1 diabetes, insulin use, recent change in OHA, recent acute infections or serious comorbidities (e.g., MI, stroke, active cancer, severe respiratory disease), malignancy in last 12 months, eating disorders or lactose intolerance, recent hypoglycemia, use of herbal/alternative anti-diabetic therapies or high-fiber or high-protein diabetic supplements, use of alpha- glucosidase inhibitors, pregnancy or lactation, or planned travel interfering with follow-up. Not part of any clinical study affecting glucose parameters in last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of DiaFiber supplementation on postprandial glucose control (CGM-based PPG assessment) in adults with uncontrolled type 2 diabetes mellitusTimepoint: Assessment Periods: o Baseline: Days 1 14 (CGM monitoring, no intervention). o Intervention: Days 22 35 and Days 91 105 (CGM monitoring with DiaFiber ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess changes in HbA1c, fasting plasma glucose, and fasting insulin. Evaluate changes in lipid parameters (TC, LDL-C, TG, Apo-B). Assess gastrointestinal tolerability (stool form, gut motility, GI symptoms). Examine glycemic variability using CGM metrics (e.g., Time in Range, Time Above Range, MAGE). Evaluate compliance with and acceptability of DiaFiber supplementationTimepoint: Each subject is followed for approximately 3.5 months (~106 days) with: baseline CGM and assessments, and an end-of-study visit | — |
Countries
India
Contacts
Public ContactDr Sanjay Agarwal
Aegles Clinic
Outcome results
None listed