Efficacy and Safety of Faster Aspart in Insulin Pumps in Children and Adolescents With Type 1 Diabetes Mellitus: A Single-center Study With Real-world Data
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1-hour glucose levels on Fiasp
研究概览
简要总结
This is an exploratory, single-center retrospective cohort real-world study comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus
详细描述
This study evaluates the effectiveness and safety of faster-acting insulin aspart (Fiasp®) compared with rapid-acting insulin analogues (insulin aspart or insulin lispro) in children and adolescents with type 1 diabetes mellitus using insulin pump therapy.
The study is a single-center retrospective cohort study including real-world clinical data from pediatric patients followed at the Pediatric Diabetes Outpatient Clinic of the 1st Pediatric Department of the Aristotle University of Thessaloniki, at Ippokratio General Hospital.
Clinical and continuous glucose monitoring data were collected from medical records during routine clinical follow-up. Patients were treated with continuous subcutaneous insulin infusion using insulin pumps equipped with continuous glucose monitoring systems.
The primary objective was to evaluate glycemic control using continuous glucose monitoring metrics, with particular emphasis on time in range (70-180 mg/dL). Secondary outcomes included time spent in hypoglycemia (<70 mg/dL), time spent in hyperglycemia (>180 mg/dL and >250 mg/dL), glycemic variability, total daily insulin dose, basal and bolus insulin distribution, and other pump-related parameters.
Comparisons were performed between patients receiving faster-acting insulin aspart and those receiving rapid-acting insulin analogues during routine clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained by parents or legal caregivers before any trial-related activities.
- •Any age, age ≥ 2 years and age <18 years at the time of signing informed consent
- •Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study
- •Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial.
- •Ability and willingness to use the same insulin infusion sets throughout the trial
- •Using the same insulin for at least 30 days prior to screening
- •HbA1c < 9.0% as assessed by local laboratory at screening
- •Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform
排除标准
- •Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
- •Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening
- •Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
- •Any diabetic complication including renal disease, retinopathy, etc
- •History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening
- •Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol
研究组 & 干预措施
Faster aspart (FIAsp)
Children and adolescents with type 1 diabetes mellitus using insulin pump therapy who received faster-acting insulin aspart.
干预措施: Fast-acting insulin aspart (Drug)
Aspart/Lispro
Children and adolescents with type 1 diabetes mellitus using insulin pump therapy receiving rapid-acting insulin analogues (insulin aspart or lispro).
干预措施: Rapid-acting insulin analogues (insulin aspart or insulin lispro) (Drug)
结局指标
主要结局
1-hour glucose levels on Fiasp
时间窗: Weeks 1 to 4
ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes.
1-hour glucose levels on Novorapid
时间窗: Weeks 1 to 4
ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes.
次要结局
- Incidence of infusion sites reactions in Novorapid(Weeks 1 to 4)
- Occlusion events in Fiasp(Weeks 1 to 4)
- Occlusion events in Novorapid(Weeks 1 to 4)
- Hypoglycemia in Fiasp(Weeks 1 to 4)
- Half-hour glucose levels on Fiasp(Weeks 1 to 4)
- Half-hour glucose levels on Novorapid(Weeks 1 to 4)
- 2 hours glucose levels on Fiasp(Weeks 1 to 4)
- 2 hours glucose levels on Novorapid(Weeks 1 to 4)
- Time in Range in Fiasp(Weeks 1 to 4)
- Time in Range in Novorapid(Weeks 1 to 4)
- Hypoglycemia in Novorapid(Weeks 1 to 4)
- Total Daily Dose in Fiasp(Weeks 1 to 4)
- Total Daily Dose in Novorapid(Weeks 1 to 4)
- Basal/Bolus in Fiasp(Weeks 1 to 4)
- Basal/Bolus in Novorapid(Weeks 1 to 4)
- eHbA1c in Fiasp(Weeks 1 to 4)
- eHbA1c in Novorapid(Weeks 1 to 4)
- Incidence of infusion sites reactions in Fiasp(Weeks 1 to 4)
研究者
Athanasios Christoforidis
Assistant Professor in Pediatric Endocrinology
Aristotle University Of Thessaloniki