Effect of Heatwave Over Glycemic Control in Patients With T1D
Effect of the Greatest Spanish Heatwave Over Glycemic Control in Adult Patients With Type 1 Diabetes
1 other identifier
observational
2,701
1 country
9
Brief Summary
Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedFebruary 10, 2023
February 1, 2023
17 days
December 2, 2022
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Time in range
Change in Time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) of interstitial glucose from the heatwave period to 14 days after its end
14 days
Secondary Outcomes (10)
Change in Adherence to Flash 1
14 days
Change in Adherence to Flash 2
14 days
Change in Time below range 1 (TBR1)
14 days
Change in Time below range 2 (TBR2)
14 days
Change in Time above range 1 (TAR1)
14 days
- +5 more secondary outcomes
Other Outcomes (1)
Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals
14 days
Study Arms (1)
Type 1 diabetes patients
Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain).
Interventions
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)
Eligibility Criteria
Adult type 1 diabetes patients using intermittently scanned continuous glucose monitoring during and after the greatest Spanish heatwave.
You may qualify if:
- 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
You may not qualify if:
- Younger than 18 years old
- Not using intermittently scanned continuous glucose monitoring
- Not having active paired isCGM data from the analyzed periods
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
La Mancha-Centro Hospital
Alcázar de San Juan, Ciudad Real, 13600, Spain
Santa Barbara Hospital
Puertollano, Ciudad Real, 13500, Spain
Valdepeñas General Hospital
Valdepeñas, Ciudad Real, 13300, Spain
Virgen del Prado Hospital
Talavera de la Reina, Toledo, 45600, Spain
Albacete University Hospital
Albacete, 02006, Spain
Ciudad Real General University Hospital
Ciudad Real, 13005, Spain
Virgen de la Luz University Hospital
Cuenca, 16002, Spain
Guadalajara University Hospital
Guadalajara, 19002, Spain
Toledo University Hospital
Toledo, 45007, Spain
Related Publications (4)
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.
PMID: 34105073BACKGROUNDMoon 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.
PMID: 33515577BACKGROUNDXu 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.
PMID: 30927429BACKGROUNDBattelino 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: 31177185RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 12, 2022
Study Start
December 15, 2022
Primary Completion
January 1, 2023
Study Completion
January 31, 2023
Last Updated
February 10, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
Under other researchers request.