Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
研究概览
简要总结
The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
详细描述
Based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need higher doses of metformin for the best treatment outcomes. The purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10-21 years
- •Provider diagnosis of T2D
- •Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose)
- •≥ 1 month from T2D diagnosis
- •Taking regular metformin (not extended-release formula)
- •Ability to wear CGM for a total of 6 weeks while in the study.
- •English or Spanish speakers.
- •Willing to abide by recommendations and study procedures.
- •Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
- •Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- •Known history of ongoing renal or hepatic disease.
- •Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
研究组 & 干预措施
Experimental
1350mg metformin twice per day
干预措施: Metformin (Drug)
Active Comparator
1000mg metformin twice per day
干预措施: Metformin (Drug)
结局指标
主要结局
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
时间窗: Measured at 3 months
The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability.
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
时间窗: Measured at 3 months
The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility.
次要结局
- Glycemic Change(Baseline (0) to 3 months)
- Time in target glucose range(Baseline (0) to 3 months)
- Time above high glucose range(Baseline (0) to 3 months)
- Time above glucose range(Baseline (0) to 3 months)
- Time in glucose range(Baseline (0) to 3 months)
- Time below glucose range(Baseline (0) to 3 months)
- Time below low glucose range(Baseline (0) to 3 months)
- Glucose management indicator(Baseline (0) to 3 months)
- Co-efficient of variation of glucose(Baseline (0) to 3 months)