Insulin Pump In Type 2 Diabetes

Real world Evidence Generation of data on use of Advanced Hybrid Closed Loop (AHCL) Technology in T2DM in India - REGAIN

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/11/076829

Enrollment

Registered

2024-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Advanced Hybrid Closed Loop: Advanced Hybrid Closed Loop 6 months Control Intervention1: Multiple daily doses of Insulin: Multiple daily doses of Insulin 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Participants with T2DM Participants who are using AHCL system Multiple daily dose insulin HbA1c values between >=8.0% and

Exclusion criteria

Exclusion criteria: A history of two or more hypoglycaemia-related seizures or comas within the last 6 months. Patients who are pregnant or planning to become pregnant are also excluded. Use of steroids or weight loss medication, abuse of alcohol or drugs. Patients currently under a psychiatristâ??s care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia.

Design outcomes

Primary

Measure	Time frame
The data collected at or near the 3 months post-automation. Time in Range 70-180 mg/dl) of the patient at the prespecified date. HbA1c change between 2 arms after 6 months.Timepoint: 1 Year	—

Secondary

Measure	Time frame
HbA1c after 3 months and change from baseline to final visit Total daily doseTimepoint: 12 months	—

Countries

India

Contacts

Public ContactDr S Poongothai

Madras Diabetes Research Foundation

drmohans@diabetes.ind.in9840134505

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026