Diabetes Mellitus, Type 1TiTR_GR1DMNCT06334484
Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics
An observational study of Diabetes Mellitus, Type 1, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Advanced hybrid closed loop systems
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2024to 26 Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with T1DM who started AHCL for at least 6 months.
Who may be able to join
- Informed consent signed before any activity related to the study
- Age ≥18 years, both sexes
- Start of AHCL for at least 6 months before enrollment (from 01/01/2021 to 31/12/2023).
Who cannot join
- 1. Diagnosis of type 2 diabetes mellitus or other forms of diabetes, such as metasteroid diabetes, secondary to pancreatectomy, related to pancreatitis or secondary to endocrinological disorders, gestational diabetes, maturity-onset diabetes of the young (MODY).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
DARIO PITOCCO, +390630155701, dario.pitocco@policlinicogemelli.it
DARIO PITOCCO
About this study
Official title: Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics, Two-years Observational Study
Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.
Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.
The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Advanced hybrid closed loop systems
- 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.
Advanced hybrid closed loop systemsDevice
Collect data from advanced hybrid closed loop users
What is being measured
The primary outcome is the main question the study is designed to answer.
change in time spent in tighter glucose range after 24 months of hybrid closed loop system
time spent in tighter glucose range (TiTR - 70-140 mg/dl or 3.9-7.8 mmol/l)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start26 Mar 2024 (estimated)
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334484
- Sponsor's protocol ID
- 6413
- Acronym
- TiTR_GR1DM
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics, Two-years Observational Study
- ClinicalTrials.gov ID
- NCT06334484
- Acronym / sponsor ID
- TiTR_GR1DM / 6413
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Mar 2024 (estimated)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 28 Mar 2024 (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.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.
Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.
The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with T1DM who started AHCL for at least 6 months.
Key inclusion criteria (3 listed)
- Informed consent signed before any activity related to the study
- Age ≥18 years, both sexes
- Start of AHCL for at least 6 months before enrollment (from 01/01/2021 to 31/12/2023).
Key exclusion criteria (1 listed)
- 1. Diagnosis of type 2 diabetes mellitus or other forms of diabetes, such as metasteroid diabetes, secondary to pancreatectomy, related to pancreatitis or secondary to endocrinological disorders, gestational diabetes, maturity-onset diabetes of the young (MODY).
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 |
|---|---|---|
| Advanced hybrid closed loop systemsCollect data from advanced hybrid closed loop users | Device | – |
Primary outcome
change in time spent in tighter glucose range after 24 months of hybrid closed loop system
Time frame: 24 months
time spent in tighter glucose range (TiTR - 70-140 mg/dl or 3.9-7.8 mmol/l)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario DFP Pitocco, Prof. (3491924858, dario.pitocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in time spent in tighter glucose range after 24 months of hybrid closed loop system (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2024.