An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of MDI Treatment With Physician Adjusted and Optimization Algorithm Adjusted Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).
研究概览
简要总结
Our lab at McGill University has developed an optimization algorithm for T1D MDI patients that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate ratios) using glucose sensor data and insulin dosing data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and ICRs. The investigators hope that this algorithm will be able to optimize the patients' individual basal injections and ICRs in order to improve glycemic control.
详细描述
The objective of this project is to compare our basal-bolus optimization algorithm with physician adjusted basal-bolus parameters using a randomized parallel clinical trial in children and adolescents at a Camp Carowanis. The investigators hypothesize that using this optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters regarding time spent in target glucose range (3.9 mmol/L - 10mmol/L).
Between 40 and 68 children and adolescent type 1 diabetes patients undergoing MDI treatment at Camp Carowanis will randomly undergo one of two interventions:
- MDI with Physician Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy. At breakfast, the research team will download the sensor data. Camp physicians will review each participant's sensor and insulin data and make changes to their parameters based on their clinical judgement, as they would for all campers, regardless of study participation. These new parameters will be entered into the patient's camp file.
- MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). At breakfast, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Camp physicians will review the algorithm's recommendations before they are entered into the patient's camp file.
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
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 8 and 18 years old.
- •Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Undergoing multiple daily injection therapy.
- •HbA1c ≤ 11%.
排除标准
- •Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- •Failure to comply with the study protocol or with team's recommendations.
- •Injection of isophane insulin (NPH) or any intermediate-acting insulin
- •More than one injection of slow-acting insulin per day.
研究组 & 干预措施
MDI with Physician Adjusted Basal-Bolus Parameters
Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy.
MDI with Basal-Bolus Optimization Algorithm
Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Once daily, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Once daily, participants' parameters may be changed based on the algorithm's recommendations.
干预措施: Multiple Daily Injections: Slow acting insulin and Rapid acting insulin (Other)
结局指标
主要结局
Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).
时间窗: the last 7 days of the study.
次要结局
- Percentage of time of sensor glucose levels spent:(last 7 days of the study)
- Percentage of overnight time (23:00-7:00) of sensor glucose levels(last 7 days of the study)
- Percentage of daytime (7:00-23:00) of sensor glucose levels(last 7 days of the study)
- Standard deviation of glucose levels as a measure of glucose variability(last 7 days of the study)
- Total insulin delivery.(last 7 days)
- Mean sensor glucose level during(last 7 days)
- Number of participants experiencing hypoglycemia requiring oral treatment during(last 7 days)