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

Recruiting

• Conditions: Type 1 Diabetes (T1D)

• Registration Number: NCT06834334
• Lead Sponsor: Castilla-La Mancha Health Service

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-19
• Study Start: 2025-02-27
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TiTR	Retrospective data from the last 14 days after study entry	Percentage differences in time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose.

Secondary Outcome Measures

Name	Time	Method
TIR	Retrospective data from the last 14 days after study entry	Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose.
Insulin use	Retrospective data from the last 14 days after study entry	Daily dose of insulin use in AHCL system (UI/day)
TAR2	Retrospective data from the last 14 days after study entry	Percentage differences in time above range 2 (\>250 mg/dL) of interstitial glucose.
TBR1	Retrospective data from the last 14 days after study entry	Percentage differences in time bellow range 1 (\<70 mg/dL) of interstitial glucose.
HbA1C	Retrospective data from the last 3 months after study entry	Differences in HbA1C values (%)
Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL)	Retrospective quality-of-life during the last 3 months	Assessing the perceived quality of life according to the EsDQOL questionnaire (with values between 46 and a maximum of 230, the higher the score the poorer the satisfaction with ACHL treatment).
TBR2	Retrospective data from the last 14 days after study entry	Percentage differences in time bellow range 2 (\<55 mg/dL) of interstitial glucose.
AHCL use	Retrospective data from the last 14 days after study entry	Percentage differences in time of use of the AHCL system (%)
Coefficient of variation	Retrospective data from the last 14 days after study entry	Percentage differences in the coefficient of variation of interstitial glucose (%)
Hypoglycemia Fear Survey (HFS questionnaire)	Retrospective fear to hypoglycemia during the last 3 months	Assessing the fear of hypoglycemia according to the HFS questionnaire (with values between 24 points and a maximum of 120 points, the higher the score the higher the fear of hypoglycemia).
Clarke's questionnaire	Retrospective hypoglycemia awareness during the last 3 months	Assessing the awareness of hypoglycemia according to Clarke's questionnaire (with values between 0 and 8 points, a score equal or greater than four indicates hypoglycemia unawareness).
TAR1	Retrospective data from the last 14 days after study entry	Percentage differences in time above range 1 (180-250 mg/dL) of interstitial glucose.

Trial Locations

Locations (3)

Hospital Universitario Mutua de Tarrasa; 🇪🇸 Terrassa, Barcelona, Spain

Badajoz University Hospital; 🇪🇸 Badajoz, Spain

Ciudad Real General University Hospital; 🇪🇸 Ciudad Real, Spain