Type 1 DiabetesUCMODYNCT05918484
Usefulness of Continuous Glucose Monitoring in MODY Diagnosis
An observational study of Type 1 Diabetes and MODY, run by Castilla-La Mancha Health Service at 9 sites in Spain.
Trial summary
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 1 Diabetes, MODY
- What is being tested?
- Intermittenly scanned continuous glucose monitoring and MODY genetic diagnostic test
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 9 sitesSpain
- Study dates
- 1 Jul 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All T1D patients using isCGM in Castilla-La Mancha Public Health Service
Who may be able to join
- 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.
Who cannot join
- Not receiving treatment with isCGM.
- Diagnosis of T1D in the last three years.
- Gestation in progress or programmed pregnancy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Albacete University Hospital
Albacete, Albacete, 02006
La Mancha-Centro Hospital
Alcázar de San Juan, Ciudad Real, 13600
Virgen de la Luz University Hospital
Cuenca, Cuenca, 16002
Guadalajara University Hospital
Guadalajara, Guadalajara, 19002
Maria Jose Picon
Málaga, Malaga, 29010
Santa Barbara Hospital
Puertollano, Ciudad Real, 13500
Virgen del Prado Hospital
Talavera de la Reina, Toledo, 45600
Toledo University Hospital
Toledo, Toledo, 45007
Valdepeñas General Hospital
Valdepeñas, Ciudad Real, 13300
About this study
Official title: Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.
Read the 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.
- Conditions
- Type 1 Diabetes, MODY
- Being tested
- Intermittenly scanned continuous glucose monitoring, MODY genetic diagnostic test
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittenly scanned continuous glucose monitoringDevice
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 testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes patients | All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain). Receives: Device: Intermittenly scanned continuous glucose monitoring; Other: MODY genetic diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 14 days
Secondary outcomes (7)
Percetage of wrongly diagnosed type 1 diabetes patients
To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100)
Measured: 14 days
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)
Measured: 14 days
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)
Measured: 14 days
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)
Measured: 14 days
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)
Measured: 14 days
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).
Measured: 14 days
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesus Moreno-Fernandez, PhD, Principal investigator, SESCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918484
- Sponsor's protocol ID
- C-621
- Acronym
- UCMODY
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Under other researchers request.
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.
PubMed 31177185Holt 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.
PubMed 34593612Tosur 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.
PubMed 35638342Broome 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.
PubMed 33034350Shields 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.
PubMed 28701371
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
- ClinicalTrials.gov ID
- NCT05918484
- Acronym / sponsor ID
- UCMODY / C-621
- Conditions
- Type 1 Diabetes, MODY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes patients | – | Device: Intermittenly scanned continuous glucose monitoring, Other: MODY genetic diagnostic testAll type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All T1D patients using isCGM in Castilla-La Mancha Public Health Service
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- Not receiving treatment with isCGM.
- Diagnosis of T1D in the last three years.
- Gestation in progress or programmed pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittenly scanned continuous glucose monitoringUse 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% | Device | Type 1 diabetes patients |
| MODY genetic diagnostic testThose 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. | Other | Type 1 diabetes patients |
Primary outcome
Positive predictive value
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
7 secondary outcomes
Percetage of wrongly diagnosed type 1 diabetes patients
Time frame: 14 days
Time in range of interstitial glucose in MODY patients
Time frame: 14 days
Time above range of interstitial glucose in MODY patients.
Time frame: 14 days
Time beloww range of interstitial glucose in MODY patients.
Time frame: 14 days
Coefficient of variation of interstitial glucose in MODY patients.
Time frame: 14 days
isCGM daily scan frequency in MODY patients
Time frame: 14 days
Percentage of iCGM in MODY patients
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 31177185Battelino 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.
- Background: PubMed 34593612Holt 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.
- Background: PubMed 35638342Tosur 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.
- Background: PubMed 33034350Broome 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.
- Background: PubMed 28701371Shields 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.
- Individual participant dataSharing planned: Yes. Under other researchers request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Moreno-Fernandez, PhD principal investigator
SESCAM
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and MODY, run by Castilla-La Mancha Health Service at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918484, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.