Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, advanced hybrid closed-loop, tight time in range, artificial pancreas
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 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.
Detailed description
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.
Interventions
DEVICEAdvanced hybrid closed-loop CamAPS FX
Treatment with a strict programmed glucose target (80-99 mg/dL).
Sponsors
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 1 diabetes. * Age greater than or equal to 18 years. * HbA1c \> 7% (previous poor glycemic control condition). * Prior treatment with MDI or aHCL.
Exclusion criteria
* Other types of diabetes. * Pregnancy or pre-conception control. * Uncontrolled psychiatric disease. * Current or previous treatment with CamAPS-Ypsopump. * No glucometric data available during the periods under study. * History of severe hypoglycemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) differences | 3 months | Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) differencies among therapies | 3 months | 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. |
| Differences between stringent glucose control targets | 3 months | To analyze the possible differences on time in range (TIR) using different interstitial glucose targets (from 80 to 99 mg/dL). |
| HbA1c differences | 3 months | Differences in HbA1c values after switching to AHCL with tighter glycemic control targets. |
| Usage of AHCL system | 3 months | To assess the effect on the time spent using AHCL systems after switching: percentage of time spent using the AHCL system. |
| MCG adherence | 3 months | To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time. |
| Total daily insulin requirements | 3 months | To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective. |
| Basal daily insulin requirements | 3 months | To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective. |
| Bolus daily insulin requirements | 3 months | To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective. |
| Time in Tight Range (TTIR 70-140 mg/dL) differences | 3 months | 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 Above Range 1 (TAR-1 >180 mg/dL) differences | 3 months | 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 Above Range 2 (TAR-2 >250 mg/dL) differences | 3 months | 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 Below Range 1 (TBR-1 <70 mg/dL) differences | 3 months | 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 Below Range 2 (TBR-2 <54 mg/dL) differences | 3 months | 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. |
| Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL). | 3 months | Episodes of hyperglycemia level 1 (nº of episodes \>180 mg/dL) after switching to aHCL with stringent glycemic control targets. |
| Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL). | 3 months | Episodes of hyperglycemia level 2 (nº of episodes \>250 mg/dL) after switching to AHCL with stringent glycemic control targets. |
| Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL). | 3 months | Episodes of hypoglycemia level 1 (nº of episodes \<70 mg/dL) after switching to AHCL with stringent glycemic control targets. |
| Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL). | 3 months | Episodes of hypoglycemia level 2 (nº of episodes \<54 mg/dL) after switching to AHCL with stringent glycemic control targets. |
| Nocturnal episodes of hypoglycemia | 3 months | Nocturnal episodes of hypoglycemia (nº of episodes \<70 and \<54 mg/dL) after switching to AHCL with stringent glycemic control targets. |
| Glycemic variability | 3 months | Glycemic variability (measured throught percentage of the coefficient of variation, CV) differences after switching to AHCL with stringent glycemic control targets. |
| Mean interstitial glucose | 3 months | Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets. |
| Glucose management indicator (GMI) | 3 months | Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets. |
| Acute complications and mortality | 3 months | 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. |
| Differences in the Percetage of patients fullfilling the International Consensus of Time in Range | 3 months | 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%). |
Countries
Spain
Outcome results
None listed