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

NCT04793165 | Completed

• 1 other identifier: 5302
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Autoimmune Diabetes

Keywords

diabetes technology; T1DM; artificial pancreas; closed-loop

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range).

  3 days

• To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl.

  3 days

Study Arms (1)

Non-hybrid closed-loop system

EXPERIMENTAL

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

Interventions

Non-hybrid closed-loop system with ARG algorithm DEVICE

To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting

Non-hybrid closed-loop system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Instituto Tecnológico de Buenos Aires: collaborator
• Universidad Nacional de La Plata: collaborator
• Fundación Nuria/Cellex: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Related Publications (2)

• 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.

  PMID: 29998754 BACKGROUND

• 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.

  PMID: 35549733 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Luis A Grosembacher, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: March 8, 2021
• Primary Completion: March 14, 2021
• Study Completion: April 8, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)