Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Test Product 1 - DiabeSmart Batter Premix (Low carb Dosa or Idli).
2. DiabeSmart Low carb Bhujia
3. Diabesmart premix atta â?? Roti
: DAY 2:
Test Product 1 Once at 0.25 Hours
Test Pro
Sponsors
Bajo Foods Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with history of prediabetes (5.7-6.4%) and Diabetes mellitus â?? type II for 1-15 years. 2. Diabetics with Hba1c >7.5%
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the study treatments, excipients, or drugs of similar chemical classes including sulfonylureas and meglitinides 2. History of type 1 diabetes 3. Subjects on insulin therapy 4. Subjects with the history of uncontrolled hypertension and/or hyperthyroidism 5. History of alcoholism 6. Subjects with psychiatric or neurological disability or mental health disorder 7. Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers. 8. Female subjects who are pregnant or had planned for pregnancy in the following months or were breast feeding. 9. Subjects who refuse to sign informed consent 10. Those who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period. 11. According to the investigatorâ??s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable 12. Any planned surgery during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Fasting Blood Sugar Test 2. Post-prandial blood glucoseTimepoint: 1. Day 1 and Day 2: at 8:00 AM 2. Day 1 and Day 2: After 1 hr. and after 2 hrs. of reference or test product consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of AETimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactSubham Dutta
Bajo Foods Pvt Ltd
Outcome results
None listed