Insulin Delivery Using the DBLG1 Closed-loop Algorithm on Glycemic Control and Patient-reported Outcomes in Adults Living With Type 1 Diabetes: a Multicenter Real-world Observational Study in Belgium
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 165
- 试验地点
- 12
- 主要终点
- Time in range
研究概览
简要总结
To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.
详细描述
This is a multicenter real-world observational study analyzing data on the use of the DBLG1 system in patients with T1D treated in the participating centers in Belgium. Data from patients with T1D who start(ed) with the DBLG1 between may-01 2022 up to and including August-01 2023 will be analyzed. Data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and CGM-data. Baseline data from before start (up to -12 months) of the DBLG1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. There are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 1 diabetes
- •aged 18 years and older
- •starting with the DBLG1 system in the participating centers
- •who signed the informed consent
排除标准
- •patients who do not have type 1 diabetes
- •younger than 18 years
- •who do not start with the DBLG1 system
- •who are not able to sign the informed consent
- •who do not want to sign the informed consent
结局指标
主要结局
Time in range
时间窗: 12 months after start
Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start of the DBLG1 system
次要结局
- Time in range [exc. primary outcome](from before start to 4,8,12 and 24 months after start, with the exclusion of the primary outcome)
- Correlation between clinical characteristics and HbA1c changes(from before start to 4,8,12 and 24 months after start)
- Time in tigh range(from before start to 4,8,12 and 24 months after start)
- Time in level 2 hypoglycemia(from before start to 4,8,12 and 24 months after start)
- Time in level 1 hypoglycemia(from before start to 4,8,12 and 24 months after start)
- Time above range(from before start to 4,8,12 and 24 months after start)
- Time in level 2 hyperglycemia(from before start to 4,8,12 and 24 months after start)
- Time in level 1 hyperglycemia(from before start to 4,8,12 and 24 months after start)
- Clarke hypoglycemia awareness survey(from before start to 4,8,12 and 24 months after start)
- Gold scale(from before start to 4,8,12 and 24 months after start)
- Time below range(from before start to 4,8,12 and 24 months after start)
- Glycemic variability(from before start to 4,8,12 and 24 months after start)
- Mean glucose concentration(from before start to 4,8,12 and 24 months after start)
- HbA1c(from before start to 4,8,12 and 24 months after start)
- Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2(from before start to 4,8,12 and 24 months after start)
- Hypoglycemia Fear Survey (HFS-II)(from before start to 4,8,12 and 24 months after start)
- PAID-SF questionnaire(from before start to 4,8,12 and 24 months after start)
- Diabetes Impact and Device Satisfaction Scale (DIDSS)(from before start to 4,8,12 and 24 months after start)
- Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs)(from before start to 4,8,12 and 24 months after start)
- Reasons to stop using the DBLG-1 device(when the patient stops using the DBLG-1 system)