Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

NCT05918484 | Completed FDA Device

• 1 other identifier: C-621
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Type 1 Diabetes; MODY

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• 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

Study Arms (1)

Type 1 diabetes patients

All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain).

Device: Intermittenly scanned continuous glucose monitoring; Other: MODY genetic diagnostic test

Interventions

Intermittenly scanned continuous glucose monitoring DEVICE

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%

Type 1 diabetes patients

MODY genetic diagnostic test OTHER

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.

Type 1 diabetes patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All T1D patients using isCGM in Castilla-La Mancha Public Health Service

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (9)

Albacete University Hospital

Albacete, Albacete, 02006, Spain

Location

La Mancha-Centro Hospital

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Santa Barbara Hospital

Puertollano, Ciudad Real, 13500, Spain

Location

Valdepeñas General Hospital

Valdepeñas, Ciudad Real, 13300, Spain

Location

Virgen de la Luz University Hospital

Cuenca, Cuenca, 16002, Spain

Location

Guadalajara University Hospital

Guadalajara, Guadalajara, 19002, Spain

Location

Maria Jose Picon

Málaga, Malaga, 29010, Spain

Location

Virgen del Prado Hospital

Talavera de la Reina, Toledo, 45600, Spain

Location

Toledo University Hospital

Toledo, Toledo, 45007, Spain

Location

Related 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.

  PMID: 31177185 BACKGROUND

• 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.

  PMID: 34593612 BACKGROUND

• 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.

  PMID: 35638342 BACKGROUND

• 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.

  PMID: 33034350 BACKGROUND

• 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.

  PMID: 28701371 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jesus Moreno-Fernandez, PhD

  SESCAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 26, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 monty after requested.
• Access Criteria: Under other researchers request and after the approval of all researchers.

Locations

ES (9)