Type 1 Diabetes Extension Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 12
- 主要终点
- Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)
研究概览
简要总结
This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D).
This observational study will:
- follow participants to determine how long they continue to produce insulin, and
- will also assess how changes in the immune system over time relate to the ability to produce insulin.
This information could help design better therapies for type 1 diabetes in the future.
详细描述
Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include:
- Overall health assessments
- Blood and urine collections
- Mixed meal tolerance test (MMTTs) for certain participants, per protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
- •Ability to sign informed consent/assent (as applicable for children).
排除标准
- •Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
- •Inability to comply with the study visit schedule and required assessments.
研究组 & 干预措施
Group 1: Detectable C-peptide by MMTT
Participants with detectable C-peptide at their:
- Last Immune Tolerance Network (ITN) T1DM week 104 study visit,
- Last AbATE (NCT00129259) follow-up visit, or
- Last ITN066AI T1DES visit
Detectable C-peptide is defined as a value above the lower limit of detection.
Group 2:Undetectable C-peptide by MMTT
Participants without detectable C-peptide at their:
- Last ITN T1DM week 104 study visit,
- Last AbATE follow-up visit, or last
- ITN066AI T1DES visit
Undetectable C-peptide is defined as a value below the lower limit of detection.
结局指标
主要结局
Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)
时间窗: Baseline (Visit 0) to Month 60 (Year 5)
Evaluation of changes in beta cell function over time will be measured by mixed-meal tolerance test (MMTT) -Stimulated mean C-Peptide area under the curve (AUC). C-peptide is released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. Detectable C-peptide is defined as any value during a MMTT of ≥0.15 ng/mL.
次要结局
- Change in Insulin Use in Units per Kilogram Body Weight Per Day(Baseline (Visit 0) to Month 60 (Year 5))
- Time to Undetectable C-Peptide(Baseline (Visit 0) to Month 60 (Year 5))
- Change in HbA1C(Baseline (Visit 0) to Month 60 (Year 5))
- Count of Participant-Reported Major Hypoglycemic Events(Baseline (Visit 0) to Month 60 (Year 5))
- Severity of Grade 3 or Higher Adverse Events (AEs) of Interest(Baseline (Visit 0) to Month 60 (Year 5))
- Frequency of Grade 3 or Higher Adverse Events (AEs) of Interest(Baseline (Visit 0) to Month 60 (Year 5))