Clinical trial NCT06834334: Clinical Effectiveness of Advanced Hybrid Closed-loop Systems for Achieving Time in Tight Range Among T1D Patients
Official title: Clinical Effectiveness of Advanced Hybrid Closed-loop Systems (AHCL) for Achieving Time in Tight Range (TiTR) of Interstitial Glucose Among Adult Type 1 Diabetes (T1D) Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes (T1D)
Keywords: Type 1 diabetes
Advanced hybrid closed-loop
Time in tight range
artificial pancreas
Control-IQ
SmartGuard
CamAPS
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
Collaborators: name: Servicio Extremeño de Salud (Spain)
name: Hospital Universitari Mutua Terrassa
First posted: 2025-02-19
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with type 1 diabetes treated with AHCL attended in any of the three centers.

Brief summary: Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control.

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.

Detailed description: Diabetes is a chronic disease with a relevant public health burden. Type 1 diabetes (T1D) is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes.
* 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:

* Other types of diabetes.
* 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.

Primary outcomes:
measure: TiTR
timeFrame: Retrospective data from the last 14 days after study entry
Secondary outcomes:
measure: TIR
timeFrame: Retrospective data from the last 14 days after study entry
measure: TAR1
timeFrame: Retrospective data from the last 14 days after study entry
measure: TAR2
timeFrame: Retrospective data from the last 14 days after study entry
measure: TBR1
timeFrame: Retrospective data from the last 14 days after study entry
measure: TBR2
timeFrame: Retrospective data from the last 14 days after study entry
measure: HbA1C
timeFrame: Retrospective data from the last 3 months after study entry
measure: AHCL use
timeFrame: Retrospective data from the last 14 days after study entry
measure: Insulin use
timeFrame: Retrospective data from the last 14 days after study entry
measure: Coefficient of variation
timeFrame: Retrospective data from the last 14 days after study entry
measure: Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL)
timeFrame: Retrospective quality-of-life during the last 3 months
measure: Hypoglycemia Fear Survey (HFS questionnaire)
timeFrame: Retrospective fear to hypoglycemia during the last 3 months
measure: Clarke's questionnaire
timeFrame: Retrospective hypoglycemia awareness during the last 3 months
Other outcomes:
measure: Differences in the Percetage of patients fullfilling the International Consensus of Time in Range
timeFrame: Retrospective data from the last 14 days after study entry
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Tarrasa
state: Barcelona
city: Badajoz
country: Spain
facility: Badajoz University Hospital
city: Ciudad Real
country: Spain
facility: Ciudad Real General University Hospital
Study officials:
affiliation: Castilla-La Mancha Health Public Service
name: Jesus Moreno Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.