Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.
The aim of this study is twofold:
- to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.
- to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Group allocation is concealed to participants as well as investigators until all participants have completed the study. The allocation for a participant may be revealed in a medical emergency if knowledge about the treatment allocation would influence the treatment of the person.
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
- •Type 1 diabetes for ≥ 5 years
- •HbA1c 53-75 mmol/mol (7.0-9.0%)
- •Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
- •CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
- •Carbohydrate counting for all snacks and meals
- •Use of the insulin pump bolus calculator for all meals and snacks
排除标准
- •Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
- •Gastroparesis (clinical assessment)
- •Shift work
- •Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
- •Use of a hybrid closed-loop system
- •Use of flash glucose monitoring
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •Chronic paracetamol use
- •Alcohol or drug abuse
- •Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
- •Impaired renal function (eGFR< 60 ml/min/1.73 m2)
- •History of local skin reactions to Fiasp and/or Iasp
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •Lack of compliance with key study procedures at the discretion of the investigator
- •Unacceptable adverse events at the discretion of the investigator
- •Less than 40 weeks guarantee remaining on insulin pump
研究组 & 干预措施
Iasp-Fiasp
First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp
干预措施: Insulin aspart (Drug)
Iasp-Fiasp
First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp
干预措施: Fast-acting insulin aspart (Drug)
Fiasp-Iasp
First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp
干预措施: Insulin aspart (Drug)
Fiasp-Iasp
First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp
干预措施: Fast-acting insulin aspart (Drug)
结局指标
主要结局
Time in range
时间窗: Last two weeks of the 16-week interventions
Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
次要结局
- Mean glucose(Last two weeks of the 16-week interventions)
- Time below range level 1(Last two weeks of the 16-week interventions)
- Total daily bolus insulin dose(Last two weeks of the 16-week interventions)
- Coefficient of variation(Last two weeks of the 16-week interventions)
- Time above range level 1(Last two weeks of the 16-week interventions)
- Time above range level 2(Last two weeks of the 16-week interventions)
- Total daily insulin dose(Last two weeks of the 16-week interventions)
- Total daily basal insulin dose(Last two weeks of the 16-week interventions)
- Time below range level 2(Last two weeks of the 16-week interventions)
- Severe hypoglycemia(16 weeks)
- Ketoacidosis(16 weeks)
- Fructosamine(16 weeks)
研究者
Kirsten Nørgaard
Senior Consultant
Steno Diabetes Center Copenhagen