NCT06414824终止不适用
The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes
Jagiellonian University4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- TBR <70 mg/dL
研究概览
简要总结
The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.
This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis.
- •Insulin therapy: multiple daily injections,
- •In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system
排除标准
- •Current or past use of any continuous glucose monitoring system.
- •Pump therapy.
- •Known allergy to medical adhesives.
- •Oral steroid therapy.
- •Pregnancy or planning pregnancy within the study duration.
- •Breast feeding.
- •Dialysis treatment.
- •Having a pacemaker.
- •Unstable coronary heart disease.
- •Cystic fibrosis.
- •Psychiatric disorders.
- •Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder.
- •Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion.
- •Participating in another clinical trial that could affect glucose measurements or glucose management.
- •In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.
结局指标
主要结局
TBR <70 mg/dL
时间窗: Baseline and days 14 to 28
Difference in time \<70 mg/dL between intervention and control group assessed in days 14 to 28
Hypoglycemia Fear Survey II
时间窗: Baseline and day 28
Change in HFS II score from baseline to day 28
次要结局
- HFS II - Worry subscale(Baseline and day 28)
- TIR(Baseline and days 14 to 28)
- TAR >250 mg/dl(Baseline and days 14 to 28)
- HFS II - Behaviour subscale(Baseline and day 28)
- TAR >180 mg/dl(Baseline and days 14 to 28)
- DKA(Baseline to day 28)
- TBR <54 mg/dL(Baseline and days 14 to 28)
- Severe hypoglycemia(Baseline to day 28)
- DDS(Baseline and day 28)
- DTSQ(Baseline and day 28)
研究者
Jerzy Hohendorff
MD, PhD
Jagiellonian University
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose DataType 1 Diabetes Mellitus With HypoglycemiaImpaired Awareness of HypoglycemiaType1diabetesNCT03028220Imperial College London40
已完成
不适用
Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic DiabetesPancreatogenic Type 3C Diabetes MellitusNCT05550480Aalborg University Hospital30
尚未招募
不适用
Efficacy of isCGM on HbA1c improvement and behavior in Japanese type 2 diabetic patientType 2 Diabetes MellitusJPRN-UMIN000043563Tokyo Teishin Hospital300
撤回
不适用
Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology GroupIron OverloadHemoglobinopathiesLymphomaAcute Lymphoblastic LeukemiaNCT03141398Hamad Medical Corporation
已完成
1 期
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)The Methodology Assessment of Glucose Dependent Insulin SecretionNCT00782418Merck Sharp & Dohme LLC27