Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Sensitive
研究概览
简要总结
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.
详细描述
Cross-sectional retrospective analysis of all patients with type 1 diabetes (T1D) in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM). This study aimed to asses the usefulness of isCGM in the diagnosis of MODY patients that were previously wrongly diagnosed as T1D patients.
The following glycometrics were taking into account as MODY predictors: time in range (70-180 mg/dL >70%, Glucose Management Index <7% y Coefficient of variation <36%. Patient´s clinical records of subjects meeting these glycometric criteria were reviewed for clinical suspicious of MODY (diagnosis before 35 years of age, first-degree family history of diabetes, negative pancreatic autoimmunity, preserved pancreatic beta cell function. Those patients meeting isCGM and clinical suspicious criteria were offered a diagnostic test for MODY.
The relationship between the qualitative outcome variable (MODY presence) and the quantitative variables will be performed using Student's t-test and ANOVA in situations of good fit with normality, and the Mann Whitney U and Kruskal Wallis when there is not a good fit with normality, and the Mann Whitney U and Kruskal Wallis when there is not.A P value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of T1D.
- •Age equal or higher than 18 years old.
- •In treatment with isCGM system.
- •Active data in Libreview.
- •isCGM use >70% of the possible time of use (isCGM data quality criteria).
- •Time in range >70%, glucose management index <7% and coefficiente of variation <36% in the last 14 days glucometric recording.
排除标准
- •Not receiving treatment with isCGM.
- •Diagnosis of T1D in the last three years.
- •Gestation in progress or programmed pregnancy.
结局指标
主要结局
Sensitive
时间窗: 14 days
Sensitive of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100)
Specificity
时间窗: 14 days
Specificity of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100)
Negative predictive value
时间窗: 14 days
Negative predictive value of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100)
Positive predictive value
时间窗: 14 days
Positive predictive value of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100)
次要结局
- Percentage of iCGM in MODY patients(14 days)
- Percetage of wrongly diagnosed type 1 diabetes patients(14 days)
- Time in range of interstitial glucose in MODY patients(14 days)
- Time above range of interstitial glucose in MODY patients.(14 days)
- Time beloww range of interstitial glucose in MODY patients.(14 days)
- Coefficient of variation of interstitial glucose in MODY patients.(14 days)
- isCGM daily scan frequency in MODY patients(14 days)