Clinical trial NCT05918484: Usefulness of Continuous Glucose Monitoring in MODY Diagnosis
Official title: Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
MODY
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All T1D patients using isCGM in Castilla-La Mancha Public Health Service

Brief summary: Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Not receiving treatment with isCGM.
* Diagnosis of T1D in the last three years.
* Gestation in progress or programmed pregnancy.

Primary outcomes:
measure: Positive predictive value
timeFrame: 14 days
measure: Negative predictive value
timeFrame: 14 days
measure: Sensitive
timeFrame: 14 days
measure: Specificity
timeFrame: 14 days
Secondary outcomes:
measure: Percetage of wrongly diagnosed type 1 diabetes patients
timeFrame: 14 days
measure: Time in range of interstitial glucose in MODY patients
timeFrame: 14 days
measure: Time above range of interstitial glucose in MODY patients.
timeFrame: 14 days
measure: Time beloww range of interstitial glucose in MODY patients.
timeFrame: 14 days
measure: Coefficient of variation of interstitial glucose in MODY patients.
timeFrame: 14 days
measure: isCGM daily scan frequency in MODY patients
timeFrame: 14 days
measure: Percentage of iCGM in MODY patients
timeFrame: 14 days
Other outcomes:
Locations:
city: Alcázar De San Juan
country: Spain
facility: La Mancha-Centro Hospital
state: Ciudad Real
city: Puertollano
country: Spain
facility: Santa Barbara Hospital
state: Ciudad Real
city: Valdepeñas
country: Spain
facility: Valdepeñas General Hospital
state: Ciudad Real
city: Málaga
country: Spain
facility: Maria Jose Picon
state: Malaga
city: Talavera De La Reina
country: Spain
facility: Virgen del Prado Hospital
state: Toledo
city: Albacete
country: Spain
facility: Albacete University Hospital
city: Cuenca
country: Spain
facility: Virgen de la Luz University Hospital
city: Guadalajara
country: Spain
facility: Guadalajara University Hospital
city: Toledo
country: Spain
facility: Toledo University Hospital
Study officials:
affiliation: SESCAM
name: Jesus Moreno-Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
citation: Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, Ludwig B, Norgaard K, Pettus J, Renard E, Skyler JS, Snoek FJ, Weinstock RS, Peters AL. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2021 Nov;44(11):2589-2625. doi: 10.2337/dci21-0043. Epub 2021 Sep 30.
citation: Tosur M, Philipson LH. Precision diabetes: Lessons learned from maturity-onset diabetes of the young (MODY). J Diabetes Investig. 2022 Sep;13(9):1465-1471. doi: 10.1111/jdi.13860. Epub 2022 Jun 16.
citation: Broome DT, Pantalone KM, Kashyap SR, Philipson LH. Approach to the Patient with MODY-Monogenic Diabetes. J Clin Endocrinol Metab. 2021 Jan 1;106(1):237-250. doi: 10.1210/clinem/dgaa710.
citation: Shields BM, Shepherd M, Hudson M, McDonald TJ, Colclough K, Peters J, Knight B, Hyde C, Ellard S, Pearson ER, Hattersley AT; UNITED study team. Population-Based Assessment of a Biomarker-Based Screening Pathway to Aid Diagnosis of Monogenic Diabetes in Young-Onset Patients. Diabetes Care. 2017 Aug;40(8):1017-1025. doi: 10.2337/dc17-0224.