Clinical Effectiveness of Advanced Hybrid Closed-loop Systems for Achieving Time in Tight Range Among T1D Patients
NCT ID: NCT06834334
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
189 participants
OBSERVATIONAL
2025-02-27
2025-12-31
Brief Summary
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This study consist of a cross-sectional observational study among adult patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose between three different advanced hybrid closed-loop (AHCL) systems.
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Detailed Description
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The use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI.
There are three main types of AHCL systems marketed in Spain: SmartGuard in Medtronic Minimed 780G (MM780G), Control-IQ in Tandem T Slim X2 (TTSX2) and CamAPS in Ypsopump (CamAPS).
All three systems have been shown indepently to significantly improve glycaemic control in people with DM1 as expressed by the classic control targets of the International Time in Range Consensus (percentage of interstitial glucose time in range 70-180 mg/dL \>70%). So much so that it has been suggested to further intensify the possible glucose targets in patients treated with AHCL systems to a time in tight range (TITR) of interstitial glucose (70-140 mg/dL) \>50%.
However, there is little information on the benefits and safety of using tighter control targets. Furthermore, there is no evidence about comparing the clinical benefit differences between these three types of technology.
The main objective is to analyze the effect on time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose between three different advanced hybrid closed-loop (AHCL) systems among adult people with T1D.
This is multicenter (3 centers) cross-sectional observational clinical study (non-randomized). The target population will be adult T1D patients treated with any of the aforementioned AHCL systems followed in any of the three participant centers.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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MM780G
Patients with type 1 diabetes treated with Medtronic Minimed 780G hybrid closed-loop systems
MM780G
SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop
TTSX2
Patients with type 1 diabetes treated with Tandem T Slim X2 hybrid closed-loop system
TTSX2
Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop
CamAPS
Patients with type 1 diabetes treated with CamAPS hybrid closed-loop system
CamAPS
CamAPS Fx in Ypsopump advanced hybrid closed-loop
Interventions
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MM780G
SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop
TTSX2
Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop
CamAPS
CamAPS Fx in Ypsopump advanced hybrid closed-loop
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years.
* Treated with advanced hybrid closed-loop systems (AHCL) for at least 3 months
* Actived continuous glucose monitoring data in the last 14 days.
Exclusion Criteria
* Receiving treatment with insulin regimens other than AHCL.
* Having received AHCL treatment for less than 3 months in a row prior to inclusion in the study with the same system.
* No data on use of the AHCL system during the previous 14 days.
* Severe or uncontrolled psychiatric disorder.
* Pregnancy or end of pregnancy less than 3 months ago or preparation for pregnancy.
18 Years
99 Years
ALL
No
Sponsors
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Servicio Extremeño de Salud (Spain)
UNKNOWN
Hospital Universitari Mutua Terrassa
UNKNOWN
Castilla-La Mancha Health Service
OTHER
Responsible Party
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Principal Investigators
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Jesus Moreno Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
Castilla-La Mancha Health Public Service
Locations
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Badajoz University Hospital
Badajoz, Badajoz, Spain
Hospital Universitario Mutua de Tarrasa
Terrassa, Barcelona, Spain
Ciudad Real General University Hospital
Ciudad Real, Ciudad Real, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S126-S144. doi: 10.2337/dc24-S007.
Di Molfetta S, Di Gioia L, Caruso I, Cignarelli A, Green SC, Natale P, Strippoli GFM, Sorice GP, Perrini S, Natalicchio A, Laviola L, Giorgino F. Efficacy and Safety of Different Hybrid Closed Loop Systems for Automated Insulin Delivery in People With Type 1 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Metab Res Rev. 2024 Sep;40(6):e3842. doi: 10.1002/dmrr.3842.
Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.
Castaneda J, Arrieta A, van den Heuvel T, Battelino T, Cohen O. Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System. Diabetes Care. 2024 May 1;47(5):790-797. doi: 10.2337/dc23-1581.
Beck RW, Raghinaru D, Calhoun P, Bergenstal RM. A Comparison of Continuous Glucose Monitoring-Measured Time-in-Range 70-180 mg/dL Versus Time-in-Tight-Range 70-140 mg/dL. Diabetes Technol Ther. 2024 Mar;26(3):151-155. doi: 10.1089/dia.2023.0380. Epub 2023 Oct 13.
Beato-Vibora PI, Chico A, Moreno-Fernandez J, Bellido-Castaneda V, Nattero-Chavez L, Picon-Cesar MJ, Martinez-Brocca MA, Gimenez-Alvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Roman A, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quiros C. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care. 2024 Feb 1;47(2):216-224. doi: 10.2337/dc23-1355.
Other Identifiers
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C-790
Identifier Type: -
Identifier Source: org_study_id
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