CompletedNCT02994277Updated Sep 12, 2025

Artificial Pancreas in Latin America

An interventional study of 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm in Diabetes, sponsored by Hospital Italiano de Buenos Aires. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Hospital Italiano de Buenos Aires · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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).

Read the detailed description

Aims:

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

Diabetes

Browse trials for

Diabetes Mellitus 10,925

Keywords

"Artificial Pancreas"
"control System"
"Closed loop"
diabetes
"T1DM"
"pump"
algorithm
CGM

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 5 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hospital Italiano de Buenos Aires is the lead sponsor of 128 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
UVa and ITBA/UNLP algorithm arm
To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm
Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm

Interventions

Device1° 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.

What researchers measure

Primary outcomes

System connectivity
Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
Time frame: 36 hours

Secondary outcomes

Technical fail rate
Time frame: 36 hours
Percentage of time in glycaemia between 70-180 mg/dl
Time frame: 36 hours
Percentage of time in glycaemia between 181-250 mg/dl
Time frame: 36 hours
Percentage of time in hypoglycaemia defined as <70 mg/dl
Time frame: 36 hours
Percentage of time in hyperglycaemia defined as >180 mg/dl
Time frame: 36 hours
Number of all hypoglycaemic events (syntomatic and non syntomatic)
Time frame: 36 hours
Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial
Time frame: 36 hours
Meal composition's effect in the efficacy of the system to control glycaemia
Time frame: 36 hours

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02994277
Lead sponsor: Hospital Italiano de Buenos Aires
Collaborators: Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Universidad Nacional de Quilmes, University of Virginia, Fundación Nuria/Cellex
Responsible party: Waldo Horacio Belloso (MD, Hospital Italiano de Buenos Aires) — Principal investigator
First posted: Dec 15, 2016
Start date: Nov 2016
Primary completion: Jul 6, 2017
Completion: Jul 7, 2017
Last update: Sep 12, 2025

Study contacts

Waldo H Belloso, MD

study director · Hospital Italiano de Buenos Aires

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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