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

July 28, 2021 updated by: Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Non-hybrid closed-loop system

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

What is the study measuring?

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.
Time Frame: 3 days
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).
Time Frame: 3 days
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.
Time Frame: 3 days
Percent of time in range of less than 70 mg/dl according to sensor glucose readings
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Universidad Nacional de La Plata
Instituto Tecnológico de Buenos Aires
Fundación Nuria/Cellex

Investigators

  • Principal Investigator: Luis A Grosembacher, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2021

Primary Completion (ACTUAL)

March 14, 2021

Study Completion (ACTUAL)

April 8, 2021

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (ACTUAL)

March 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Non-hybrid closed-loop system with ARG algorithm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe