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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793165
• Other study ID #: 5302
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: April 8, 2021

Study information

• Verified date: March 2021
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 8, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Non-hybrid closed-loop system with ARG algorithm
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Fundación Nuria/Cellex, Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Sánchez-Peña R, Colmegna P, Garelli F, De Battista H, García-Violini D, Moscoso-Vásquez M, Rosales N, Fushimi E, Campos-Náñez E, Breton M, Beruto V, Scibona P, Rodriguez C, Giunta J, Simonovich V, Belloso WH, Cherñavvsky 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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