Clinical trial NCT04793165: Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
Official title: Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe for Ambulatory Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Autoimmune Diabetes
Keywords: diabetes technology
T1DM
artificial pancreas
closed-loop
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Instituto Tecnológico de Buenos Aires
name: Universidad Nacional de La Plata
name: Fundación Nuria/Cellex
First posted: 2021-03-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting.
timeFrame: 3 days
Secondary outcomes:
measure: To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range).
timeFrame: 3 days
measure: To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl.
timeFrame: 3 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Luis A Grosembacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Pena R, Colmegna P, Garelli F, De Battista H, Garcia-Violini D, Moscoso-Vasquez M, Rosales N, Fushimi E, Campos-Nanez E, Breton M, Beruto V, Scibona P, Rodriguez C, Giunta J, Simonovich V, Belloso WH, Chernavvsky D, Grosembacher L. Artificial Pancreas: Clinical Study in Latin America Without Premeal Insulin Boluses. J Diabetes Sci Technol. 2018 Sep;12(5):914-925. doi: 10.1177/1932296818786488. Epub 2018 Jul 12.
citation: Garelli F, Fushimi E, Rosales N, Arambarri D, Mendoza L, Serafini MC, Moscoso-Vasquez M, Stasi M, Duette P, Garcia-Arabehety J, Giunta JN, De Battista H, Sanchez-Pena R, Grosembacher L. First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America. J Diabetes Sci Technol. 2023 Jul;17(4):1008-1015. doi: 10.1177/19322968221096162. Epub 2022 May 12.