Type 1 DiabetesNCT04793165
Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
A study testing Non-hybrid closed-loop system with ARG algorithm in people with Type 1 Diabetes and Autoimmune Diabetes, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Autoimmune Diabetes
- What is being tested?
- Non-hybrid closed-loop system with ARG algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteArgentina
- Study dates
- 8 Mar 2021to 8 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes, Autoimmune Diabetes
- Being tested
- Non-hybrid closed-loop system with ARG algorithm
- Keywords
- diabetes technology, T1DM, artificial pancreas, closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-hybrid closed-loop system with ARG algorithmDevice
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Non-hybrid closed-loop system with ARG algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (2)
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
Measured: 3 days
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start8 Mar 2021
- Primary completion14 Mar 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Fundación Nuria/Cellex
- Responsible party
- Sponsor
- Investigators
- Luis A Grosembacher, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793165
- Sponsor's protocol ID
- 5302
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29998754Garelli 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.
PubMed 35549733
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe for Ambulatory Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04793165
- Acronym / sponsor ID
- 5302
- Conditions
- Type 1 Diabetes, Autoimmune Diabetes
- Keywords
- diabetes technology, T1DM, artificial pancreas, closed-loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Instituto Tecnológico de Buenos Aires, Universidad Nacional de La Plata, Fundación Nuria/Cellex
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-hybrid closed-loop system | Experimental | Device: Non-hybrid closed-loop system with ARG algorithmTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-hybrid closed-loop system with ARG algorithmTo assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting | Device | Non-hybrid closed-loop system |
Primary outcome
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
2 secondary outcomes
To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range).
Time frame: 3 days
To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 29998754Sanchez-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.
- Derived from this study: PubMed 35549733Garelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Grosembacher, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-hybrid closed-loop system with ARG algorithm in people with Type 1 Diabetes and Autoimmune Diabetes, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.