Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time in Range (TIR) differences
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Time in Range (TIR) differences
时间窗: 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.
次要结局
- Basal daily insulin requirements(3 months)
- Time Below Range 1 (TBR-1 <70 mg/dL) differences(3 months)
- Time in Range (TIR) differencies among therapies(3 months)
- Differences between stringent glucose control targets(3 months)
- HbA1c differences(3 months)
- Usage of AHCL system(3 months)
- MCG adherence(3 months)
- Bolus daily insulin requirements(3 months)
- Total daily insulin requirements(3 months)
- Time Above Range 1 (TAR-1 >180 mg/dL) differences(3 months)
- Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).(3 months)
- Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).(3 months)
- Acute complications and mortality(3 months)
- Differences in the Percetage of patients fullfilling the International Consensus of Time in Range(3 months)
- Time in Tight Range (TTIR 70-140 mg/dL) differences(3 months)
- Time Above Range 2 (TAR-2 >250 mg/dL) differences(3 months)
- Time Below Range 2 (TBR-2 <54 mg/dL) differences(3 months)
- Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).(3 months)
- Glycemic variability(3 months)
- Mean interstitial glucose(3 months)
- Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).(3 months)
- Nocturnal episodes of hypoglycemia(3 months)
- Glucose management indicator (GMI)(3 months)