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.
Diabetes is a chronic disease with a relevant public health burden. 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. On the one hand, 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. On the other hand, among the adjustment parameters of these systems, each AHCL offers different target levels of glycemic control. There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR, improvement in the other glycometric variables, as well as the development of acute or chronic complications. In this regard, a new AHCL system has recently been introduced in Spain: CamAPS FX. It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL. However, there is no information on the benefits and safety of using tighter control targets. The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature. This is monocenter prospective analytical clinical study (non-randomized). The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital.
Study Type
OBSERVATIONAL
Enrollment
40
Treatment with a strict programmed glucose target (80-99 mg/dL).
Ciudad Real General University Hospital
Ciudad Real, Spain
RECRUITINGTime 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.
Time frame: 3 months
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.
Time frame: 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).
Time frame: 3 months
HbA1c differences
Differences in HbA1c values after switching to AHCL with tighter glycemic control targets.
Time frame: 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.
Time frame: 3 months
MCG adherence
To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time.
Time frame: 3 months
Total daily insulin requirements
To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective.
Time frame: 3 months
Basal daily insulin requirements
To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective.
Time frame: 3 months
Bolus daily insulin requirements
To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Mean interstitial glucose
Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets.
Time frame: 3 months
Glucose management indicator (GMI)
Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets.
Time frame: 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.
Time frame: 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: 3 months
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