NCT03263494已完成3 期
CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-<25 With Type 1 Diabetes
Jaeb Center for Health Research18 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2018年1月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 18
- 主要终点
- Change in HbA1c from baseline to 26 weeks adjusted for baseline
研究概览
简要总结
Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.
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
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T1D, with either age of T1D diagnosis < 10 years of age OR a history of positive T1D related antibodies in the medical record
- •Age 14-<25 years
- •Diabetes duration ≥ 1 year
- •Total daily insulin requirement ≥ 0.4 units/kg/day
- •HbA1c 7.5% to <11.0% (Point of care device or local lab measured as part of study at screening visit)
- •Insulin regimen involves a consistent modality of insulin administration with either use of an insulin pump or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin. Insulin pump must not have been started within 3 months of consent with no plans to change regimens in the next 6 months
- •Perform at least 2 blood glucose meter checks per day from self-report at screening and an average of at least 2 checks per day from meter download during blinded CGM run in
- •Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an average of 1.8 calibrations per day during the blinded CGM screening period.
- •Participant comprehends written and spoken English
- •Participant understands the study protocol and agrees to it (if applicable)
排除标准
- •Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
- •Unable to use CGM device for minimum number of hours during blinded pre-randomization period or skin reaction from adhesive that would preclude participation in the randomized trial
- •Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months
- •The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors (such as a skin condition), or the completion of any aspect of the protocol.
- •More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.
- •The presence of any of the following diseases:
- •Asthma or any condition present in the last 6 months where treatment is a systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
- •Cystic fibrosis
- •Addison's disease (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
- •Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.
- •Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.
- •Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
- •Participation in a diabetes related intervention study in the past 6 weeks.
- •Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention
- •Any condition, per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin administration within 3 months prior to screening
研究组 & 干预措施
CGM
Active Comparator
干预措施: Continuous Glucose Monitor (CGM) (Device)
BGM
No Intervention
结局指标
主要结局
Change in HbA1c from baseline to 26 weeks adjusted for baseline
时间窗: 6 months
次要结局
- % with HbA1c <7.5%(6 months)
- CGM mean glucose(6 months)
- % with HbA1c <7.0%(6 months)
- % with absolute reduction ≥ 0.5%(6 months)
- CGM % time in range 70-180 mg/dl(6 months)
- % with relative reduction ≥ 10%(6 months)
- % with absolute reduction ≥ 1%(6 months)
- % with absolute reduction ≥ 1% or HbA1c < 7.0%(6 months)
- CGM glucose variability measured by coefficient of variation(6 months)
- CGM % time < 70 mg/dl(6 months)
- CGM % time > 180 mg/dl(6 months)
- CGM % time > 300 mg/dl(6 months)
- CGM % time < 54 mg/dl(6 months)
- CGM Self Efficacy Questionnaire Score(6 months)
- Hypoglycemia Confidence Questionnaire Score(6 months)
- Rate of CGM measured hypoglycemic episodes (using <54 mg/dL)(6 months)
- Problem Areas in Diabetes (PAID) Questionnaire Score(6 months)
- Glucose Monitoring Satisfaction Questionnaire Score(6 months)
- Diabetes Technology Attitudes Questionnaire Score(6 months)
- Pittsburgh Sleep Quality Index(6 months)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 DiabetesType 1 DiabetesNCT01586065Nemours Children's Clinic10
已完成
不适用
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic ControlType 1 Diabetes MellitusNCT00945659Nemours Children's Clinic116
已完成
不适用
Home-Based Interventions for Adolescents With Type 1 DiabetesType 1 DiabetesNCT02243072Wayne State University49
已完成
不适用
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education SessionsType 1 Diabetes in AdolescenceNCT02859779Assistance Publique Hopitaux De Marseille40
Enrolling By Invitation
不适用
The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes ManagementMotivational InterviewingType 1 DiabetesNCT06208618Eskisehir Osmangazi University96