Artificial Pancreas in Latin America

NCT ID: NCT02994277

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-07-07

Brief Summary

The purpose of this study is to use closed-loop systems with the algorithms designed by the University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).

Detailed Description

Aims:

1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours at our facilities.

2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm without meal announcement to maintain glucose control for 2 periods of 12 hours

In both cases, the adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time .

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVa and ITBA/UNLP algorithm arm

To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm

Group Type: EXPERIMENTAL

1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm

Intervention Type: DEVICE

The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.

Interventions

1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm

The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient have been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit.
• Patient is >18 and <65 years.
• Patient has HbA1c > 6.5 % and < 10%.
• Woman in premenopausal age agrees to use contraceptive methods.
• Woman in premenopausal age has negative B-HCG in the tests performed in the trial.
• Patient is trained in carbohydrates counting.
• Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits.

Exclusion Criteria

• Patient has been hospitalized for diabetic ketoacidosis in the last 12 months.
• Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months.
• Patient has a history of coronary disease or cardiac failure.
• Patient with uncontrolled arterial hypertension.
• Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia.
• Patient has symptoms compatible with an active infectious disease.
• Patient has Cystic Fibrosis.
• Pregnant women, or women with the intention of getting pregnant; women breastfeeding.
• Patient has been hospitalized for psychiatric treatment in the last 6 months.
• Patient with a diagnosis of an adrenal disease.
• Patient has abnormal laboratory values for liver function: transaminase > 2x upper limit of normal.
• Patient has abnormal laboratory values for renal function: GFR < 60 ml/min/1.73m2
• Patient has active gastroparesis.
• Patient is under oncological treatment.
• Patient has taken acetaminophen 72 hours previous to the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Tecnológico de Buenos Aires

OTHER

Sponsor Role: collaborator

Universidad Nacional de La Plata

OTHER

Sponsor Role: collaborator

Universidad Nacional de Quilmes

UNKNOWN

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Fundación Nuria/Cellex

UNKNOWN

Sponsor Role: collaborator

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Waldo Horacio Belloso

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldo H Belloso, MD

Role: STUDY_DIRECTOR

Hospital Italiano de Buenos Aires

Other Identifiers

2680

Identifier Type: -

Identifier Source: org_study_id