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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 867
- 试验地点
- 3
- 主要终点
- Time in range (TIR, 70-180 mg/dL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •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)
排除标准
- •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)
研究组 & 干预措施
investigational group
Participants of the FUTURE study who switched during the study to Gla-300
干预措施: Insulin Glargine 300 UNT/ML [Toujeo] (Drug)
结局指标
主要结局
Time in range (TIR, 70-180 mg/dL)
时间窗: maximum 24 months
The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
次要结局
- HbA1c(maximum 24 months)
- Time in range (TIR, 70-180 mg/dL)(maximum 24 months)
- Hypoglycemia(maximum 24 months)
- Hyperglycemia(maximum 24 months)
- Mean glycemia(maximum 24 months)
- Glycemic variability(maximum 24 months)
- Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire(maximum 24 months)
- Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry(maximum 24 months)
- Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire(maximum 24 months)
- Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)(maximum 24 months)
研究者
prof dr Pieter Gillard
Principal Investigators
Universitaire Ziekenhuizen KU Leuven