Usefulness of Continuous Glucose Monitoring in MODY Diagnosis
NCT ID: NCT05918484
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2023-07-01
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Type 1 diabetes patients
All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain).
Intermittenly scanned continuous glucose monitoring
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre) and meeting the glycometric data criteria:
* Time in range 70-180 mg/L \>70%
* Glycemic management index \<7%
* Coefficient of variation \<36%
MODY genetic diagnostic test
Those patients fulfilling the glycometric data criteria and with clinical MODY suspicion:
* diagnosis before 35 years of age
* first-degree family history of diabetes.
* negative pancreatic autoimmunity (Ac GAD, IA-2A and Ac ZnT8)
* preserved pancreatic beta cell function defined as C-peptide \> 0.2 ng/mL in the presence of plasma glycemia \>140 mg/dL).
Those patients who meet the previous criteria will proceed to the MODY genetic diagnostic test.
Interventions
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Intermittenly scanned continuous glucose monitoring
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre) and meeting the glycometric data criteria:
* Time in range 70-180 mg/L \>70%
* Glycemic management index \<7%
* Coefficient of variation \<36%
MODY genetic diagnostic test
Those patients fulfilling the glycometric data criteria and with clinical MODY suspicion:
* diagnosis before 35 years of age
* first-degree family history of diabetes.
* negative pancreatic autoimmunity (Ac GAD, IA-2A and Ac ZnT8)
* preserved pancreatic beta cell function defined as C-peptide \> 0.2 ng/mL in the presence of plasma glycemia \>140 mg/dL).
Those patients who meet the previous criteria will proceed to the MODY genetic diagnostic test.
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of T1D in the last three years.
* Gestation in progress or programmed pregnancy.
18 Years
100 Years
ALL
No
Sponsors
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Castilla-La Mancha Health Service
OTHER
Responsible Party
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Principal Investigators
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Jesus Moreno-Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
SESCAM
Locations
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Albacete University Hospital
Albacete, Albacete, Spain
La Mancha-Centro Hospital
Alcázar de San Juan, Ciudad Real, Spain
Santa Barbara Hospital
Puertollano, Ciudad Real, Spain
Valdepeñas General Hospital
Valdepeñas, Ciudad Real, Spain
Virgen de la Luz University Hospital
Cuenca, Cuenca, Spain
Guadalajara University Hospital
Guadalajara, Guadalajara, Spain
Maria Jose Picon
Málaga, Malaga, Spain
Virgen del Prado Hospital
Talavera de la Reina, Toledo, Spain
Toledo University Hospital
Toledo, Toledo, Spain
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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C-621
Identifier Type: -
Identifier Source: org_study_id
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