Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL (FUTURE-GLARE)
2022年8月29日 更新者：prof dr Pieter Gillard
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy
Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.
Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).
Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).
The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.
研究概览
研究类型
观察性的
注册 (实际的)
867
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Aalst、比利时、9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Edegem、比利时、2650
- Universitair Ziekenhuis Antwerpen
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Leuven、比利时、3000
- Universitaire Ziekenhuizen Leuven
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
People with type 1 diabetes who participated in the FUTURE study.
描述
Investigational group
Inclusion Criteria:
- participant in the FUTURE study
- diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
- use of insulin pens for the entirety of the FUTURE study
- used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®)
- switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)
Exclusion Criteria:
- use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300
- not using bolus insulin (only basal insulin)
- for women: pregnant or planning pregnancy during the FUTURE study
- Control group
Inclusion Criteria:
- participant in the FUTURE study for at least 18 months
- diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
- use of insulin pens for the entirety of the FUTURE study
- use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study
Exclusion Criteria:
- use of Fast-acting insulin aspart (Fiasp®)
- not using bolus insulin (only basal insulin)
- for women: pregnant or planning pregnancy during the FUTURE study
- switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 [Toujeo®] or Insulin Degludec [Tresiba®] will be used for this control participant)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
investigational group
Participants of the FUTURE study who switched during the study to Gla-300
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Switch during standard routine care to Gla-300.
|
|
control group
Participants of the FUTURE study who did not switch to Insulin Gla-300
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time in range (TIR, 70-180 mg/dL)
大体时间：maximum 24 months
|
The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
|
maximum 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HbA1c
大体时间：maximum 24 months
|
difference in HbA1c
|
maximum 24 months
|
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Time in range (TIR, 70-180 mg/dL)
大体时间：maximum 24 months
|
difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
|
Hypoglycemia
大体时间：maximum 24 months
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difference in time in hypoglycemia (<54 mg/dL, <70 mg/dL, ≥54-<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
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Hyperglycemia
大体时间：maximum 24 months
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difference in time in hyperglycemia (>180 mg/dL, >250 mg/dL, >180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
|
Mean glycemia
大体时间：maximum 24 months
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difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
|
Glycemic variability
大体时间：maximum 24 months
|
difference in glycemic variability (standard deviation, coefficient of variation; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
|
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
大体时间：maximum 24 months
|
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
|
maximum 24 months
|
|
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry
大体时间：maximum 24 months
|
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
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maximum 24 months
|
|
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
大体时间：maximum 24 months
|
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
|
maximum 24 months
|
|
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)
大体时间：maximum 24 months
|
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))
|
maximum 24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insulin dose
大体时间：maximum 24 months
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difference in insulin dose (basal, bolus and total)
|
maximum 24 months
|
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Body mass index
大体时间：maximum 24 months
|
difference in body mass index (BMI)
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maximum 24 months
|
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Severe hypoglycemia rate
大体时间：maximum 24 months
|
difference in self-reported severe hypoglycemic events
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maximum 24 months
|
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Hypoglycemic coma rate
大体时间：maximum 24 months
|
difference in self-reported hypoglycemic comas
|
maximum 24 months
|
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Hospitalization
大体时间：maximum 24 months
|
difference in hospitalizations due to hypoglycemia or ketoacidosis
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maximum 24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pieter Gillard, MD, PhD、Universitaire Ziekenhuizen KU Leuven
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年9月8日
初级完成 (实际的)
2021年10月14日
研究完成 (实际的)
2021年10月14日
研究注册日期
首次提交
2021年10月14日
首先提交符合 QC 标准的
2021年11月3日
首次发布 (实际的)
2021年11月5日
研究记录更新
最后更新发布 (实际的)
2022年8月30日
上次提交的符合 QC 标准的更新
2022年8月29日
最后验证
2022年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.