Artificial Pancreas in Latin America

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994277
• Other study ID #: 2680
• Status: Completed
• Phase: N/A
• First received: December 13, 2016
• Last updated: November 7, 2017
• Start date: November 2016
• Est. completion date: July 7, 2017

Study information

• Verified date: November 2017
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in patients with type 1 diabetes mellitus (T1DM).

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 7, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Fundación Nuria/Cellex, Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Universidad Nacional de Quilmes, University of Virginia

Outcome

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