Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)
NCT Number: NCT06466967
Acronym: TightT1AHCL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Interventions: DEVICE: Advanced hybrid closed-loop CamAPS FX
Sponsor: Castilla-La Mancha Health Service
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-15
Completion Date: 2026-04-15
Locations: Ciudad Real General University Hospital, Ciudad Real, 13005, Spain

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 prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.

Primary Outcome Measures: Time in Range (TIR) differences, Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets., 3 months
Secondary Outcome Measures: Time in Range (TIR) differencies among therapies, Percentage differences in time in range (TIR 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets depending on previous therapy: multi-dose insulin or other AHCL systems with less stringent objectives., 3 months|Differences between stringent glucose control targets, To analyze the possible differences on time in range (TIR) using different interstitial glucose targets (from 80 to 99 mg/dL)., 3 months|HbA1c differences, Differences in HbA1c values after switching to AHCL with tighter glycemic control targets., 3 months|Usage of AHCL system, To assess the effect on the time spent using AHCL systems after switching: percentage of time spent using the AHCL system., 3 months|MCG adherence, To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time., 3 months|Total daily insulin requirements, To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective., 3 months|Basal daily insulin requirements, To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective., 3 months|Bolus daily insulin requirements, To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective., 3 months|Time in Tight Range (TTIR 70-140 mg/dL) differences, Percentage differences in time in tight range (TIR 70-140 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets., 3 months|Time Above Range 1 (TAR-1 >180 mg/dL) differences, Percentage differences in Time Above Range 1 (TAR-1 \>180 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets., 3 months|Time Above Range 2 (TAR-2 >250 mg/dL) differences, Percentage differences in Time Above Range 2 (TAR-2 \>250 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets., 3 months|Time Below Range 1 (TBR-1 <70 mg/dL) differences, Time and percentage differences in Time Below Range 1 (TBR-1 \<70 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets., 3 months|Time Below Range 2 (TBR-2 <54 mg/dL) differences, Time and percentage differences in Time Below Range 2 (TBR-2 \<54 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets., 3 months|Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL)., Episodes of hyperglycemia level 1 (nº of episodes \>180 mg/dL) after switching to aHCL with stringent glycemic control targets., 3 months|Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL)., Episodes of hyperglycemia level 2 (nº of episodes \>250 mg/dL) after switching to AHCL with stringent glycemic control targets., 3 months|Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL)., Episodes of hypoglycemia level 1 (nº of episodes \<70 mg/dL) after switching to AHCL with stringent glycemic control targets., 3 months|Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL)., Episodes of hypoglycemia level 2 (nº of episodes \<54 mg/dL) after switching to AHCL with stringent glycemic control targets., 3 months|Nocturnal episodes of hypoglycemia, Nocturnal episodes of hypoglycemia (nº of episodes \<70 and \<54 mg/dL) after switching to AHCL with stringent glycemic control targets., 3 months|Glycemic variability, Glycemic variability (measured throught percentage of the coefficient of variation, CV) differences after switching to AHCL with stringent glycemic control targets., 3 months|Mean interstitial glucose, Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets., 3 months|Glucose management indicator (GMI), Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets., 3 months|Acute complications and mortality, Analyzing the impact of the switch on the frequency of acute complications and mortality due to T1D: severe hypoglycemia, non-acidotic ketotic hyperglycemia, diabetic ketoacidosis, hospital admissions and deaths., 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%)., 3 months
Other Outcome Measures: 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 indicating a high fear of hypoglycemia) after switching to AHCL with stringent glycemic control targets., 3 months|Diabetes Treatment Satisfaction Questionnaire (DTSQ), Assessing the satisfaction with treatment according to the DTSQ questionnaire (options graduated from 0 to 6 from the lowest to the highest degree of satisfaction, with a minimum of 0 and a maximum of 12) after switching to AHCL with stringent glycemic control targets., 3 months|Clarke's questionnaire, Assessing the awareness of hypoglycemia according to Clarke's questionnaire (indicates high risk of inadvertent hypoglycemia with a score equal to or greater than four) afterswitching to AHCL with stringent glycemic control targets., 3 months|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 which would indicate poor satisfaction with current treatment) after switching to AHCL with stringent glycemic control targets., 3 months