Clinical Effectiveness of Advanced Hybrid Closed-loop Systems for Achieving Time in Tight Range Among T1D Patients

NCT06834334 | Completed FDA Device

• 1 other identifier: C-790
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 diabetes; Advanced hybrid closed-loop; Time in tight range; artificial pancreas; Control-IQ; SmartGuard; CamAPS

Outcome Measures

Primary Outcomes (1)

• TiTR

  Percentage differences in time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose.

  Retrospective data from the last 14 days after study entry

Secondary Outcomes (12)

• TIR

  Retrospective data from the last 14 days after study entry

• TAR1

  Retrospective data from the last 14 days after study entry

• TAR2

  Retrospective data from the last 14 days after study entry

• TBR1

  Retrospective data from the last 14 days after study entry

• TBR2

  Retrospective data from the last 14 days after study entry

Other Outcomes (1)

• Differences in the Percetage of patients fullfilling the International Consensus of Time in Range

  Retrospective data from the last 14 days after study entry

Study Arms (3)

MM780G

Patients with type 1 diabetes treated with Medtronic Minimed 780G hybrid closed-loop systems

Device: MM780G

TTSX2

Patients with type 1 diabetes treated with Tandem T Slim X2 hybrid closed-loop system

Device: TTSX2

CamAPS

Patients with type 1 diabetes treated with CamAPS hybrid closed-loop system

Device: CamAPS

Interventions

MM780G DEVICE

SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop

Also known as: Medtronic Minimed 780G

MM780G

TTSX2 DEVICE

Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop

Also known as: Tandem T Slim X2

TTSX2

CamAPS DEVICE

CamAPS Fx in Ypsopump advanced hybrid closed-loop

Also known as: CamAPS Fx

CamAPS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 1 diabetes treated with AHCL attended in any of the three centers.

You may qualify if:

• 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.

You may not qualify if:

• Other types of diabetes.
• Receiving treatment with insulin regimens other than AHCL.
• 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.

Sponsors & Collaborators

• Hospital Universitari Mutua Terrassa: collaborator
• Castilla-La Mancha Health Service: lead
• Servicio Extremeño de Salud (Spain): collaborator

Study Sites (3)

Badajoz University Hospital

Badajoz, Badajoz, 06080, Spain

Location

Hospital Universitario Mutua de Tarrasa

Terrassa, Barcelona, 08221, Spain

Location

Ciudad Real General University Hospital

Ciudad Real, Ciudad Real, 13005, Spain

Location

Related Publications (6)

• 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.

  PMID: 38078575 BACKGROUND

• 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.

  PMID: 39298688 BACKGROUND

• 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.

  PMID: 37067353 BACKGROUND

• 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.

  PMID: 38113453 BACKGROUND

• 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.

  PMID: 37870460 BACKGROUND

• 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.

  PMID: 37948469 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jesus Moreno Fernandez, PhD

  Castilla-La Mancha Health Public Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 19, 2025
• Study Start: February 27, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

ES (3)