Data-driven Coaching Intervention in Achieving Glycemic Control in Uncontrolled Type II Diabetics

Study to Evaluate the Efficacy of a Doctor-led Digital Diabetes Program Aided by a Data-driven Coaching Intervention Process in Achieving Better Glycemic Control in Uncontrolled Type II Diabetics - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015530

Enrollment

Registered

2018-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E08-E13- Diabetes mellitus

Interventions

Intervention1: Type 2 diabetes mellitus: 40 Subjects on Keto diet 40 Subjects on Normal T2DM diet Control Intervention1: Type 2 diabetes mellitus: 40 Subjects on Keto diet 40 Subjects on Normal T2DM d

Eligibility

Inclusion criteria

Inclusion criteria: Type II Diabetes Mellitus subjects of either sex aged 18 to 65years. HbA1c value greater than 7.0%. Subjects able to provide written informed consent. Subjects using android mobile. Agree to follow Keto/T2DM diet and use Keto calculator app. If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study.

Exclusion criteria

Exclusion criteria: Subjects with deteriorating health status at the time of enrolment; rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, gastro-intestinal disease, irritable bowel syndrome). Recent blood donation (within 3 months from the date of screening). Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection). Pregnant or breast feeding women. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. Conditions in the opinion of the investigator make the patient unsuitable to participate in the study. Any contraindication to blood sampling.

Design outcomes

Primary

Measure	Time frame
To compare the glycaemic levels (HbA1c, FBG, PPBG) in uncontrolled type II diabetes patients being managed by conventional treatment compared to those being managed nutritional ketosis using a connected digital health platformTimepoint: 3 months	—

Secondary

Measure	Time frame
To compare weight loss, Body mass index changes, Insulin and medication requirement, compliance to prescribed medication, visit and lab test schedule between the above two groups at the end of a three-month periodTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Arun Kumar

CURO Health Services

Partha@lifeincontrol.com9958398699

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026