Artificial Pancreas in Latin America

NCT02994277 | Completed

• 1 other identifier: 2680
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

UVa and ITBA/UNLP algorithm arm

EXPERIMENTAL

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

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

Interventions

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

UVa and ITBA/UNLP algorithm arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Instituto Tecnológico de Buenos Aires: collaborator
• Universidad Nacional de La Plata: collaborator
• Universidad Nacional de Quilmes: collaborator
• University of Virginia: collaborator
• Fundación Nuria/Cellex: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Waldo H Belloso, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: November 1, 2016
• Primary Completion: July 6, 2017
• Study Completion: July 7, 2017
• Last Updated: September 12, 2025

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share