An observational study in Type 1 Diabetes (T1D), sponsored by Castilla-La Mancha Health Service. Completed at 3 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Castilla-La Mancha Health Service · Observational
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.
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.
Adult patients with type 1 diabetes treated with AHCL attended in any of the three centers.
Exclusion Criteria:
Patients with type 1 diabetes treated with Medtronic Minimed 780G hybrid closed-loop systems
Device: MM780G
Patients with type 1 diabetes treated with Tandem T Slim X2 hybrid closed-loop system
Device: TTSX2
Patients with type 1 diabetes treated with CamAPS hybrid closed-loop system
Device: CamAPS
SmartGuard in Medtronic Minimed 780G advaced hybrid closed-loop
Also known as: Medtronic Minimed 780G
Control-IQ in Tandem T Slim X2 advanced hybrid closed-loop
Also known as: Tandem T Slim X2
CamAPS Fx in Ypsopump advanced hybrid closed-loop
Also known as: CamAPS Fx
TiTR
Percentage differences in time in tight range (TiTR, 70-140 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
TIR
Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
TAR1
Percentage differences in time above range 1 (180-250 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
TAR2
Percentage differences in time above range 2 (\>250 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
TBR1
Percentage differences in time bellow range 1 (\<70 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
TBR2
Percentage differences in time bellow range 2 (\<55 mg/dL) of interstitial glucose.
Time frame: Retrospective data from the last 14 days after study entry
HbA1C
Differences in HbA1C values (%)
Time frame: Retrospective data from the last 3 months after study entry
AHCL use
Percentage differences in time of use of the AHCL system (%)
Time frame: Retrospective data from the last 14 days after study entry
Insulin use
Daily dose of insulin use in AHCL system (UI/day)
Time frame: Retrospective data from the last 14 days after study entry
Coefficient of variation
Percentage differences in the coefficient of variation of interstitial glucose (%)
Time frame: Retrospective data from the last 14 days after study entry
Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL)
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).
Time frame: Retrospective quality-of-life during the last 3 months
Hypoglycemia Fear Survey (HFS questionnaire)
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).
Time frame: Retrospective fear to hypoglycemia during the last 3 months
Clarke's questionnaire
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).
Time frame: Retrospective hypoglycemia awareness during the last 3 months
Differences in the Percetage of patients fullfilling the International Consensus of Time in Range
Differences in the Percetage of patients fullfilling the International Consensus of Time in Range (TAR2 \<5%, TAR1 \<25%, TIR \>70%, TBR1 \<4%, TBR2 \<1%, CV\>36%).
Time frame: Retrospective data from the last 14 days after study entry
Plan to share: Undecided — Under request and after consideration from all investigators.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Castilla-La Mancha Health Service