Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Time in Range( 70-180 mg/dl)
研究概览
简要总结
Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia.
The objective of this study is to evaluate whether a simplified approach for patients' follow up using preset of pump settings and a simplified meal announcement, followed by minimal interaction can achieve similar glycemic control of AHCL system MiniMed 780G with Guardian Sensor 4 than a regular protocol that is currently used in adolescents with Type 1 Diabetes (T1D).
Methods. This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study. Participants will be randomized in two groups: Group 1, Regular Clinical Protocol, 17 participants and Group 2, Simplified Clinical Protocol, 17 participants.
All patients will be recruited during the regular clinic visits to the outpatient Endocrine Clinics at Sidra Medicine in Doha. Patients will be chosen on a first-come first-served basis. Inclusion criteria: Clinical diagnosis of type 1 diabetes, , Age 12-18 years, Basal Bolus therapy >8.0 units per day. Exclusion criteria: Diabetic Ketoacidosis (DKA) in the 6 months prior to screening visit. The initiation protocol consists of four stages: HCL system compatibility assessment, HCL system training, Manual Mode Start and Auto Mode start. Patients will have 7 visits in a period of 3 months after initiation of insulin pump therapy.
Pump initiation: Group 1, Finetune ICR, Target 100 or 110 mg/dl and AIT: 2-3 hour and Group 2, Carb Ratio by formula 360 / TDD, ICR 8-10 (TDD 40-60), ICR 5-7 (TDD >60), Target 100 mg/dl, AIT: 2 hours with fixed meals Results. No group difference in Time in Range (TIR) (70-180mg/dl) > 70% and HbA1c < 7.5% in a period of 3 months after initiation of AHCL.
Conclusion. Conclusions will be drawn on completion of the study and evaluation of the results.
详细描述
This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study.
Participants will be randomized in two groups:
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Group 1, Regular Clinical Protocol, 17 participants
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Group 2, Simplified Clinical Protocol, 17 participants Intervention Description
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Intervention in Group 2, Simplified protocol.
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Insulin Carb Ratio (ICR) by formula 360 / Total Daily Dose (TDD)
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ICR 8-10 (TDD 40-60)
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ICR 5-7 (TDD >60)
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Target 100 mg/dl
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Active Insulin Time (AIT): 2 hours
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Meals: Thee sets of meal set of meals announcement carbs calculated by the following formula:
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 (Care Provider)
盲法说明
Eligible subjects shall be randomly assigned to Group 1 or Group 2 in a 1:1 ratio using a computer-generated randomization scheme developed by the data manager.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes >0.5 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •Age 12-18 years and above at the initiation of the system
- •Total daily insulin use of great than 8.0 units per day over a 1-week period
- •Willing and able (access to internet from home)
- •Clinically able to start the AHCL system
排除标准
- •Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
- •Currently in other Clinical Trial
结局指标
主要结局
Time in Range( 70-180 mg/dl)
时间窗: Third month
Group change in the third month of AHCL use
次要结局
- HbA1c(3 months)
- Average Sensor Glucose(3 months)
- Time Bellow Range (<70 mg/dl, <54 mg/dl)(3 months)
- Time Above Range (>180 mg/dl)(3 months)
- Diabetic Ketoacidosis(3 months)
- Severe Hypoglycemia(3 months)