The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 6
研究概览
简要总结
Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin pump, there is an opportunity to reduce the basal insulin rate during exercise. This study is being conducted to determine if decreasing the insulin that is received during exercise will reduce the risk of hypoglycemia. We hope to learn more about how the body responds to hypoglycemia and to hyperglycemia (high blood sugar) when it occurs.
As part of the study, children will have a visit on two different days. During each visit, children will exercise on a treadmill for about 60 minutes. During one of the visits, the children's basal rate will be continued during the exercise. During one visit, the basal insulin will be stopped. The blood sugar will be checked frequently during the exercise.
详细描述
Each child will have two study visits. The visits will be between 1 and 4 weeks apart. The child will come to the research unit at the hospital at about 11:30 a.m. and will have lunch in the clinic.
- If the child has had a severe hypoglycemia episode in the 2 weeks before a visit or is ill at the time of either visit, the visit will be rescheduled.
The parent and child will be asked if they want to use a meter to test the child's hemoglobin A1c at home. If they want to do this, they will be given the meter and asked to test the child's A1c two times on the day before one of the visits. The two tests will be done at the same time and they will also be asked to check the child's blood sugar at the same time. The test involves a fingerstick similar to testing the blood sugar level with a home glucose meter.
At the start of each visit, a continuous glucose sensor will be inserted under the skin. This is done either in the stomach area, side, or buttock depending on which area looks like it will work best for the child. A special cream may be used to numb the skin before this sensor is placed. At the end of each visit, the child will have the option of removing the sensor or wearing it home for continued use.
During each visit, blood samples will be drawn frequently to measure glucose and other hormones. To make the blood sampling easier, a small tube, called a catheter, will be placed in a vein in the child's arm. A special cream may be used to numb the skin before the tube is placed. The tube will stay in the vein while the child is in the hospital. There may be some itching, stinging or pain from having the tube in the vein. However, there should be no pain when blood is drawn through the tube. If the tube stops working, a new one will need to be inserted.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for at least 18 months (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- •HbA1c <10.0% (The DCA2000 will be used to assess eligibility.)
- •Age 8.0 to <18.0 years
- •Weight >39.5 kg at reinfusion centers and >46.0 kg at discard centers
- •BMI >5th and <95th percentiles for age and gender
- •Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump.)
- •Insulin regimen involves use of an insulin pump
- •Normal thyroid function (measured within the previous year)
排除标准
- •A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- •Asthma which has been medically treated within the last year
- •Current use of glucocorticoid medication (by any route of administration)
- •Current use of a beta blocker medication
- •Use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
- •Active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred)
- •Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport)