Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting

Study Overview
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Brief Summary
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This is a pilot, interventional clinical trial to assess the effectiveness and safety of artificial pancreas (AP) using the ARG algorithm closed-loop system in a monitored 3-day period outpatient study. Once the safety of the device has been validated in the open-loop first 3-day period (continuous subcutaneous insulin infusion (CSII) plus continuous glucose monitoring (CGM)) the investigators will move the study to the second 3-day closed-loop period, without carbohydrate (CHO) counting.

Official Title
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Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe for Ambulatory Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Autoimmune Diabetes

Intervention / Treatment
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* Device: Non-hybrid closed-loop system with ARG algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been diagnosed with T1DM at least two years ago and has 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 < 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 CHO 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 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 adrenal disease Patient has abnormal laboratory values for liver function: transaminase > 2x upper limit 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-hybrid closed-loop system<br>To compare two types of treatments: During the first 3 days: Previous or conventional, with CSII plus CGM in open loop. During the second 3 day period: AP with CSII plus CGM in a closed-loop system, through the ARG algorithm. | Device: Non-hybrid closed-loop system with ARG algorithm<br>* To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting. | Percent of time in each range according to sensor glucose readings | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range). | Percent of time in the target range of 70-180 mg/dl according to sensor glucose readings | 3 days | 
| To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl. | Percent of time in range of less than 70 mg/dl according to sensor glucose readings | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes technology, T1DM, artificial pancreas, closed-loop