Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Lower beta hydroxybutyrate levels
研究概览
简要总结
This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.
详细描述
This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/L at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays. To remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment
- •HbA1c ≥8.5%9 and <14% on enrollment
- •Taking no medications known to affect blood glucose levels other than insulin.
- •Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is < age 18 before any trial-related activities
- •Current regimen includes insulin detemir or I-glar, as long acting insulin
- •Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration
- •Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week
- •Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check
排除标准
- •Female participants who are pregnant, breast-feeding or planning on becoming pregnant
- •Participant (and parent if age <18) unable to read, write, and speak English.
- •Adolescents who are home schooled or no longer attending secondary school
- •Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels
- •Known or suspected allergy to trial medication(s), excipients, or related products.
- •Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia
研究组 & 干预措施
subjects receiving insulin degludec
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.
干预措施: Insulin Degludec (Drug)
Subjects receiving insulin glargine
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Lower beta hydroxybutyrate levels
时间窗: 4 months
Will test the the hypothesis that β-hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving I-deg, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays.
次要结局
- Control of HbA1c levels(4 months)
- Measure of beta hydroxybutyrate levels between the 2 groups.(4 months)