A Customizable and Intelligent Artificial Pancreas a type of insulin pump for Type-1 Diabetic Patients of India

A Customizable and Intelligent Artificial Pancreas for Type-1 Diabetic Patients of India - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106705

Enrollment

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: E109- Type 1 diabetes mellitus without complications

Interventions

Intervention1: Subcutaneous injection of 0.2U/Kg of insulin: Subcutaneous injection of 0.2U/Kg of insulin lispro at t=0 (insulin is given within 10 seconds using INSULIN PEN). Control Intervention1: N

Eligibility

Inclusion criteria

Inclusion criteria: a. Age between 18 to 30 years of age b. Body mass index of less than 26 kg per m2, c. HbA1c less than or equal 10 percentage, d. Creatinine level less than or equal to 1.5 mg per dL

Exclusion criteria

Exclusion criteria: a. Significant gastrointestinal symptoms by questionnaire b. Hypoglycaemia unawareness documented by Clarke s questionnaire c. Documented recent upper gastrointestinal disorder, d. Medications affecting gastric motility (e.g., erythromycin), pregnancy, breast feeding, or other comorbidities (e.g., nephropathy, neuropathy, macrovascular disease, hypertension). e. Those with stable background diabetic retinopathy will be included. f. Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance will be excluded. g. Subjects who would have engaged in vigorous physical activities for 72 h before the screening and study visits h. Acute stress state i. Patients on antidiabetic agents other than insulin will be excluded.

Design outcomes

Primary

Measure	Time frame
1.Build on the existing Artificial Pancreas system developed at IISc to make it fully autonomous to regulate glucose 24x7. 2.Include AI-enabled meal and exercise detection capabilities to improve the functionality of the AP system. 3.Develop a smart, decision support system called AP Assist that suggests insulin doses and provides vital information to patients Timepoint: From Base line to end of study at 24:00 Hour of day 2	—

Measure

Time frame

1.Build on the existing Artificial Pancreas system developed at IISc to make it fully autonomous to regulate glucose 24x7. 2.Include AI-enabled meal and exercise detection capabilities to improve the functionality of the AP system. 3.Develop a smart, decision support system called AP Assist that suggests insulin doses and provides vital information to patients Timepoint: From Base line to end of study at 24:00 Hour of day 2

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactMr Mukesh Kumar

Government Institute of Medical Sciences(GIMS)

drpayaljainn@gmail.com9560307790

Outcome results

None listed

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