Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

Type 1 Diabetes Clinical Trial

— UCMODY  

Official title:

Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918484
• Other study ID #: C-621
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Castilla-La Mancha Health Service
• Contact: Jesus Moreno-Fernandez
• Phone: 926278000
• Email: jmorenof[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• MODY
• Type 1 Diabetes

Intervention

Device:
• 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%

Other:
• 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.

Locations

Country	Name	City	State
Spain	Albacete University Hospital	Albacete
Spain	La Mancha-Centro Hospital	Alcázar De San Juan	Ciudad Real
Spain	Virgen de la Luz University Hospital	Cuenca
Spain	Guadalajara University Hospital	Guadalajara
Spain	Maria Jose Picon	Málaga	Malaga
Spain	Santa Barbara Hospital	Puertollano	Ciudad Real
Spain	Virgen del Prado Hospital	Talavera De La Reina	Toledo
Spain	Toledo University Hospital	Toledo
Spain	Valdepeñas General Hospital	Valdepeñas	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive value	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)	14 days
Primary	Negative predictive value	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)	14 days
Primary	Sensitive	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)	14 days
Primary	Specificity	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)	14 days
Secondary	Percetage of wrongly diagnosed type 1 diabetes patients	To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100)	14 days
Secondary	Time in range of interstitial glucose in MODY patients	To assess the percetage of time in range (70-180 mg/dL, 3.9-10 mmol/L) of interstitial glucose in patients finally diagnosed as MODY. Units % (min 0, max 100)	14 days
Secondary	Time above range of interstitial glucose in MODY patients.	To assess the percentage of time above range (>180 mg/dL, >10 mmol/L) of patients finally diagnosed as MODY. Units % (min 0, max 100)	14 days
Secondary	Time beloww range of interstitial glucose in MODY patients.	To assess the percentage of time bellow range (<70 mg/dL, <3.9 mmol/L) of patients finally diagnosed as MODY. Units % (min 0, max 100)	14 days
Secondary	Coefficient of variation of interstitial glucose in MODY patients.	To assess the coefficient of variations of patients finally diagnosed as MODY. Units % (min 0, max 100)	14 days
Secondary	isCGM daily scan frequency in MODY patients	To analyze the use of iCGM in patients finally diagnosed as MODY through daily frequency of scanning (number daily scans, min 0-max 100).	14 days
Secondary	Percentage of iCGM in MODY patients	To analyze the percentage of iCGM use in patients finally diagnosed as MODY (% time in use, units %, mix 0- max 100).	14 days