DiabetesNCT02994277
Artificial Pancreas in Latin America
A study testing 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm in people with Diabetes, run by Hospital Italiano de Buenos Aires.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
About this study
Official title: 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).
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
- Diabetes
- Being tested
- 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm
- Keywords
- "Artificial Pancreas", "control System", "Closed loop", diabetes, "T1DM", "pump", algorithm, CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| UVa and ITBA/UNLP algorithm arm | Experimental | To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm Receives: Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
System connectivity
Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
Measured: 36 hours
Secondary outcomes (8)
Technical fail rate
Measured: 36 hours
Percentage of time in glycaemia between 70-180 mg/dl
Measured: 36 hours
Percentage of time in glycaemia between 181-250 mg/dl
Measured: 36 hours
Percentage of time in hypoglycaemia defined as <70 mg/dl
Measured: 36 hours
Percentage of time in hyperglycaemia defined as >180 mg/dl
Measured: 36 hours
Number of all hypoglycaemic events (syntomatic and non syntomatic)
Measured: 36 hours
Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial
Measured: 36 hours
Meal composition's effect in the efficacy of the system to control glycaemia
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion6 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Universidad Nacional de Quilmes, University of Virginia, Fundación Nuria/Cellex
- Responsible party
- Principal investigator, Waldo Horacio Belloso, Hospital Italiano de Buenos Aires
- Investigators
- Waldo H Belloso, MD, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994277
- Sponsor's protocol ID
- 2680
- Status last verified
- Nov 2017
- First submitted
- 13 Dec 2016
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Automatic Glycaemic Correction Systems (Closed-loop) in Patients With Type 1 Diabetes Mellitus With Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT02994277
- Acronym / sponsor ID
- 2680
- Conditions
- Diabetes
- Keywords
- "Artificial Pancreas", "control System", "Closed loop", diabetes, "T1DM", "pump", algorithm, CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Universidad Nacional de Quilmes, University of Virginia, Fundación Nuria/Cellex
- Study start
- Nov 2016
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UVa and ITBA/UNLP algorithm arm | Experimental | Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithmTo control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithmThe 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. | Device | UVa and ITBA/UNLP algorithm arm |
Primary outcome
System connectivity
Time frame: 36 hours
Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldo H Belloso, MD study director
Hospital Italiano de Buenos Aires
Questions about this trial
What is this clinical trial studying?
A study testing 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm in people with Diabetes, run by Hospital Italiano de Buenos Aires.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System connectivity (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.