Effect of Heatwave Over Glycemic Control in Patients With T1D

Study Overview
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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.

Official Title
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Effect of the Greatest Spanish Heatwave Over Glycemic Control in Adult Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Intermittenly scanned continuous glucose monitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetes patients<br>Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain). | Device: Intermittenly scanned continuous glucose monitoring<br>* Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)<br>* Other names: FSL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adherence to Flash 1 | Change in Time of use of intermittently scanned continuous glucose monitoring (% possible time of use) from the heatwave period to 14 days after its end | 14 days | 
| Change in Adherence to Flash 2 | Change in Number of intermittently scanned continuous glucose monitoring daily scanning (number of scans/day) from the heatwave period to 14 days after its end | 14 days | 
| Change in Time below range 1 (TBR1) | Change in Time bellow range <3.9 mmol/L (<70 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its endfrom the heatwave period to 14 days after its end | 14 days | 
| Change in Time below range 2 (TBR2) | Change in Time bellow range <3 mmol/L (<54 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Time above range 1 (TAR1) | Change in Time above range >10 mmol/L(>180 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Time above range 2 (TAR2) | Change in Time above range >13.9 mmol/L (>250 mg/dL) of the interstitial glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Coefficient of variation percentage (CV) | Change in Coefficient of variation percentage of interstitial glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Glucose management index | Change in Glucose management index of interstitial glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Time in hypoglycemia | Change in Daily time in hypoglycemia (<3.9 mmol/L, <70 mg/dL) of interstitical glucose from the heatwave period to 14 days after its end | 14 days | 
| Change in Hypoglycemia frequency | Change in Number of daily hypoglycemic events (<3.9 mmol/L, <70 mg/dL) of interstitical glucose from the heatwave period to 14 days after its end | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Type 1 diabetes