NCT06834334

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 189 (actual)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
DEVICE	MM780G	SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop
DEVICE	TTSX2	Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop
DEVICE	CamAPS	CamAPS Fx in Ypsopump advanced hybrid closed-loop

Timeline

• Start date: 2025-02-27
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-02-19
• Last updated: 2026-03-19

Locations

3 sites across 1 country: Spain

Regulatory

• FDA-regulated device study