Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
研究概览
简要总结
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.
详细描述
This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.
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
- 2 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged 2-24 years
- •Clinical diagnosis of Type 1 diabetes mellitus
- •Duration of diabetes: At least 6 months
- •This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
- •Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- •This will provide a uniform method of insulin therapy.
- •Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
- •Willingness to wear the iPro®2 for 5 days continuously per insertion
- •Participant agrees to comply with the study protocol requirements
- •Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian
排除标准
- •Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
- •Glucocorticoid use within 2 weeks of study enrollment
- •Concurrent use of other medications that may affect glycemic control
- •Prior CGM use in the past 6 months
- •The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®
- •Non-English or non-Spanish speaking
研究组 & 干预措施
CGM Informed
CGM data was available for use when determining starting insulin pump doses.
干预措施: CGM Informed (Device)
Control
CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
结局指标
主要结局
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
时间窗: First 6 weeks of insulin pump therapy
次要结局
- Percentage Time Hyperglycemic(First 6 weeks of insulin pump therapy)
- Total Number of Phone Calls to Clinic Hotline(First 6 weeks of insulin pump therapy)
- Mean Blood Glucose (mg/dL)(First 6 weeks of insulin pump therapy)
- Total Number of Episodes of Severe Hypoglycemia(First 6 weeks of insulin pump therapy)
- Hemoglobin A1c (%)(Baseline to 3 months post-pump start)
- Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)(First 5 days of insulin pump therapy)
- Total Number of Insulin Dose Adjustments(First 6 weeks of insulin pump therapy)
- Episodes of DKA(First 6 weeks of insulin pump therapy)
- Number of Participants With Satisfaction of Transition to Pump Therapy(At 6 weeks after start of insulin pump therapy)
- Total Daily Insulin Dose (Units)(First 6 weeks of insulin pump therapy)
- Percentage Basal Insulin (%)(First 6 weeks of insulin pump therapy)
- Number of Insulin Dose Adjustments Made Per Phone Call(First 6 weeks of insulin pump therapy)
研究者
Jessica Ferris, MD
Clinical Fellow
Children's Hospital Los Angeles