Effect of Heatwave Over Glycemic Control in Patients With T1D

NCT ID: NCT05646017

Last Updated: 2023-02-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2701 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-01-31

Brief Summary

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Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.

Detailed Description

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Cross-sectional retrospective analysis of all patients with T1D in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM). Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. 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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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Type 1 diabetes patients

Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain).

Intermittenly scanned continuous glucose monitoring

Intervention Type DEVICE

Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)

Interventions

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Intermittenly scanned continuous glucose monitoring

Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)

Intervention Type DEVICE

Other Intervention Names

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FreeStyle Libre isCGM FSL

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* Older than 18 years old
* Using intermittently scanned continuous glucose monitoring (isCGM)
* Paired active isCGM data from the heatwave period and two consecutive weeks

Exclusion Criteria

* Younger than 18 years old
* Not using intermittently scanned continuous glucose monitoring
* Not having active paired isCGM data from the analyzed periods
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castilla-La Mancha Health Service

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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La Mancha-Centro Hospital

Alcázar de San Juan, Ciudad Real, Spain

Site Status

Santa Barbara Hospital

Puertollano, Ciudad Real, Spain

Site Status

Valdepeñas General Hospital

Valdepeñas, Ciudad Real, Spain

Site Status

Virgen del Prado Hospital

Talavera de la Reina, Toledo, Spain

Site Status

Albacete University Hospital

Albacete, , Spain

Site Status

Ciudad Real General University Hospital

Ciudad Real, , Spain

Site Status

Virgen de la Luz University Hospital

Cuenca, , Spain

Site Status

Guadalajara University Hospital

Guadalajara, , Spain

Site Status

Toledo University Hospital

Toledo, , Spain

Site Status

Countries

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Spain

References

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Song X, Jiang L, Zhang D, Wang X, Ma Y, Hu Y, Tang J, Li X, Huang W, Meng Y, Shi A, Feng Y, Zhang Y. Impact of short-term exposure to extreme temperatures on diabetes mellitus morbidity and mortality? A systematic review and meta-analysis. Environ Sci Pollut Res Int. 2021 Nov;28(41):58035-58049. doi: 10.1007/s11356-021-14568-0. Epub 2021 Jun 8.

Reference Type BACKGROUND
PMID: 34105073 (View on PubMed)

Moon J. The effect of the heatwave on the morbidity and mortality of diabetes patients; a meta-analysis for the era of the climate crisis. Environ Res. 2021 Apr;195:110762. doi: 10.1016/j.envres.2021.110762. Epub 2021 Jan 27.

Reference Type BACKGROUND
PMID: 33515577 (View on PubMed)

Xu Z, Tong S, Cheng J, Crooks JL, Xiang H, Li X, Huang C, Hu W. Heatwaves and diabetes in Brisbane, Australia: a population-based retrospective cohort study. Int J Epidemiol. 2019 Aug 1;48(4):1091-1100. doi: 10.1093/ije/dyz048.

Reference Type BACKGROUND
PMID: 30927429 (View on PubMed)

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.

Reference Type RESULT
PMID: 31177185 (View on PubMed)

Related Links

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Other Identifiers

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C-566

Identifier Type: -

Identifier Source: org_study_id

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