Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 17
- 主要终点
- percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)
研究概览
简要总结
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.
The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.
It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.
25 centers involved in this study.
After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.
They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.
The study will take place in 5 weeks:
During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:
- moderate activity 3 hours after lunch
- intense activity 3 hours after lunch
- activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.
Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.
During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.
Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.
Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient aged over 18 years
- •Patient with type 1 diabetes for at least 1 year
- •Patient receiving insulin pump under basal-prandial regimen for at least 3 months
- •Patient practicing functional insulin therapy, or using a fixed plane defined food
- •Patients with a stable basal rate for at least 1 week
- •Patient practicing regular physical activity and reproducible identically
- •Patient with HbA1c older than 3 months between 6.5% and 9.5% (HbA1c ≤ 6.5% ≤ 9.5%)
- •Patients with BMI ≤ 35
- •Patient who agreed to participate in the study and who signed an informed consent
- •Patient not participating in another protocol
- •Patient covered by social security
排除标准
- •Patients with a history of severe hypoglycemia without accidental cause in the 6 months preceding the entry in the protocol
- •Patient not receiving its hypoglycaemia below the threshold of 0.5 g / L
- •Patient with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure
- •Patient with poorly controlled hypertension
- •Pregnant woman
- •Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship
研究组 & 干预措施
Diabrasport then Rest
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Usual algorithm (Behavioral)
Diabrasport then Rest
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Diabrasport algorithm (Behavioral)
Diabrasport then Rest
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Rest (Behavioral)
Diabrasport then Rest
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Holter Glycemic Ipro2, Medtronic (Device)
Rest then Diabrasport
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Holter Glycemic Ipro2, Medtronic (Device)
Rest then Diabrasport
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Usual algorithm (Behavioral)
Rest then Diabrasport
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Diabrasport algorithm (Behavioral)
Rest then Diabrasport
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
干预措施: Rest (Behavioral)
结局指标
主要结局
percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)
时间窗: 24h
the number of hypoglycemic events, defined by any threshold crossing 60 mg / dL (3.33mmol / L), measured in the interstitial glucose sensor continuously over a period of 24h
时间窗: 24h
percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)
时间窗: 24h
次要结局
- Number of hypoglycemic events, defined by any threshold crossing 70 mg / dL (3.9 mml / L), and <54 mg / dL (3 mmol / l) measured by interstitial continuous glucose sensors(1 week)
- Number of hyperglycemic events, defined by any crossing of the threshold of 180 mg / dL (10 mml / L), measured by continuous interstitial glucose sensors.(1 week)
- Nadirs analysis of blood glucose during the night (time to onset)(1 week)
- Metabolic goals analysis:(1 week)
- Nadirs analysis of blood glucose during the night (value reached)(1 week)
- Analysis of quantities of glucose administration consumed during and at the waning of physical activity(1 week)
- Comparison between number of hypoglycemic events predicted by the prediction function "DIABRASPORT" and number of hypoglycemic events actually occurred.(1 week)
- Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA)(1 week)
- Comparison of average values of continuous glucose measurements according to the period (DIABRASPORT, rest and Baseline) and at different times of the day and night.(1 week)
- Analysis by subgroups, depending on the type of physical activity and its duration, a link between a typology of physical activity or patients, and the number of hypoglycemia events during or waning of physical activity(1 week)