UCMODY: Usefulness of Continuous Glucose Monitoring in MODY Diagnosis
Study Details
Study Description
Brief Summary
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
|
Outcome Measures
Primary Outcome Measures
- Positive predictive value [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)
- Negative predictive value [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)
- Sensitive [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 [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)
Secondary Outcome Measures
- Percetage of wrongly diagnosed type 1 diabetes patients [14 days]
To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100)
- Time in range of interstitial glucose in MODY patients [14 days]
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)
- Time above range of interstitial glucose in MODY patients. [14 days]
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)
- Time beloww range of interstitial glucose in MODY patients. [14 days]
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)
- Coefficient of variation of interstitial glucose in MODY patients. [14 days]
To assess the coefficient of variations of patients finally diagnosed as MODY. Units % (min 0, max 100)
- isCGM daily scan frequency in MODY patients [14 days]
To analyze the use of iCGM in patients finally diagnosed as MODY through daily frequency of scanning (number daily scans, min 0-max 100).
- Percentage of iCGM in MODY patients [14 days]
To analyze the percentage of iCGM use in patients finally diagnosed as MODY (% time in use, units %, mix 0- max 100).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presence of T1D.
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Age equal or higher than 18 years old.
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In treatment with isCGM system.
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Active data in Libreview.
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isCGM use >70% of the possible time of use (isCGM data quality criteria).
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Time in range >70%, glucose management index <7% and coefficiente of variation <36% in the last 14 days glucometric recording.
Exclusion Criteria:
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Not receiving treatment with isCGM.
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Diagnosis of T1D in the last three years.
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Gestation in progress or programmed pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | La Mancha-Centro Hospital | Alcázar De San Juan | Ciudad Real | Spain | 13600 |
| 2 | Santa Barbara Hospital | Puertollano | Ciudad Real | Spain | 13500 |
| 3 | Valdepeñas General Hospital | Valdepeñas | Ciudad Real | Spain | 13300 |
| 4 | Maria Jose Picon | Málaga | Malaga | Spain | 29010 |
| 5 | Virgen del Prado Hospital | Talavera De La Reina | Toledo | Spain | 45600 |
| 6 | Albacete University Hospital | Albacete | Spain | 02006 | |
| 7 | Virgen de la Luz University Hospital | Cuenca | Spain | 16002 | |
| 8 | Guadalajara University Hospital | Guadalajara | Spain | 19002 | |
| 9 | Toledo University Hospital | Toledo | Spain | 45007 |
Sponsors and Collaborators
- Castilla-La Mancha Health Service
Investigators
- Principal Investigator: Jesus Moreno-Fernandez, PhD, SESCAM
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- C-621