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Completed

NCT Number: NCT05646017

Effect of Heatwave Over Glycemic Control in Patients With T1D

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittenly scanned continuous glucose monitoring

Device

Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)

Other names: FreeStyle Libre, isCGM, FSL

Primary outcomes

  1. Change in Time in range

    Time frame: 14 days

    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

Secondary outcomes

  1. Change in Adherence to Flash 1

    Time frame: 14 days

    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

  2. Change in Adherence to Flash 2

    Time frame: 14 days

    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

  3. Change in Time below range 1 (TBR1)

    Time frame: 14 days

    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

  4. Change in Time below range 2 (TBR2)

    Time frame: 14 days

    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

  5. Change in Time above range 1 (TAR1)

    Time frame: 14 days

    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

  6. Change in Time above range 2 (TAR2)

    Time frame: 14 days

    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

  7. Change in Coefficient of variation percentage (CV)

    Time frame: 14 days

    Change in Coefficient of variation percentage of interstitial glucose from the heatwave period to 14 days after its end

  8. Change in Glucose management index

    Time frame: 14 days

    Change in Glucose management index of interstitial glucose from the heatwave period to 14 days after its end

  9. Change in Time in hypoglycemia

    Time frame: 14 days

    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

  10. Change in Hypoglycemia frequency

    Time frame: 14 days

    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

Other outcomes

  1. Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals

    Time frame: 14 days

    Change in Percentage of patients (from total) attaining TIR>70%, TBR1<4%, TBR2<1%, TAR1<25%, TAR2<5% and CV <36% from the heatwave period to 14 days after its end

Sponsors and collaborators

Lead sponsor

Castilla-La Mancha Health Service

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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