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

Hospital Italiano de Buenos Aires1 site in 1 country5 target enrollmentMarch 8, 2021

ConditionsType 1 Diabetes Autoimmune Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Hospital Italiano de Buenos Aires
Enrollment: 5
Locations: 1
Primary Endpoint: To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2021

End Date

April 8, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospital Italiano de Buenos Aires

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)