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

Artificial Pancreas in Latin America

Sponsors

Lead sponsor: Hospital Italiano de Buenos Aires

Collaborator: Instituto Tecnológico de Buenos Aires
Universidad Nacional de La Plata
Universidad Nacional de Quilmes
University of Virginia
Fundación Nuria/Cellex

Source Hospital Italiano de Buenos Aires
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).

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 .

Overall Status Completed
Start Date November 2016
Completion Date July 7, 2017
Primary Completion Date July 6, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
System connectivity 36 hours
Secondary 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
Enrollment 5
Condition
Intervention

Intervention type: Device

Intervention name: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm

Description: 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.

Arm group label: UVa and ITBA/UNLP algorithm arm

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Waldo H Belloso, MD Study Director Hospital Italiano de Buenos Aires
Verification Date

November 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: UVa and ITBA/UNLP algorithm arm

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov