Artificial Pancreas in Latin America

Pilot Study of Automatic Glycaemic Correction Systems (Closed-loop) in Patients With Type 1 Diabetes Mellitus With Continuous Subcutaneous Insulin Infusion

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).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm

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 .

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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 is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Collaborators: University of Virginia; Universidad Nacional de La Plata; Universidad Nacional de Quilmes; Instituto Tecnológico de Buenos Aires; Fundación Nuria/Cellex
• Investigators: Study Director: Waldo H Belloso, MD, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimated): December 15, 2016

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; algorithm; CGM; "Artificial Pancreas"; "control System"; "Closed loop"; "T1DM"; "pump"
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO