Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
Primary Purpose
Type 1 Diabetes, Autoimmune Diabetes
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Non-hybrid closed-loop system with ARG algorithm
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes focused on measuring diabetes technology, T1DM, artificial pancreas, closed-loop
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
Sites / Locations
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-hybrid closed-loop system
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04793165
First Posted
March 8, 2021
Last Updated
July 28, 2021
Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Fundación Nuria/Cellex
1. Study Identification
Unique Protocol Identification Number
NCT04793165
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
March 14, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires
Collaborators
Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Fundación Nuria/Cellex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Autoimmune Diabetes
Keywords
diabetes technology, T1DM, artificial pancreas, closed-loop
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-hybrid closed-loop system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Non-hybrid closed-loop system with ARG algorithm
Intervention Description
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
Primary Outcome Measure Information:
Title
To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting.
Description
Percent of time in each range according to sensor glucose readings
Time Frame
3 days
Secondary Outcome Measure Information:
Title
To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range).
Description
Percent of time in the target range of 70-180 mg/dl according to sensor glucose readings
Time Frame
3 days
Title
To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl.
Description
Percent of time in range of less than 70 mg/dl according to sensor glucose readings
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Grosembacher, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29998754
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.
Results Reference
background
PubMed Identifier
35549733
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.
Results Reference
derived
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Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
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