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Completed

NCT Number: NCT06214780

Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas

To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas

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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

Observational retrospective study to analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with advanced hybrid closed-loop systems in the Castilla-La Mancha region (southcentral Spain). Main objective is the difference in time in range of intersticial glucose between 3.0-10 mmol/L (70-180 mg/d) measured throught real-time continuous glucose monitoring during the two consecutive greatest heatwave during summer 2024 (5th-26th August) comparted to the following period (27th August to 17th September). 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

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

Inclusion criteria

  • Type 1 diabetes
  • Older than 18 years old
  • Using advanced hybrid closed-loop systems (AHCL)
  • Paired active AHCL data from the heatwave periods and two consecutive weeks

Exclusion criteria

  • Younger than 18 years old
  • Not using AHCL
  • Not having active paired AHCL data from the analyzed periods

Treatment and study plan

advanced hybrid closed-loop

Device

An advanced hybrid closed-loop system is a type of insulin delivery system that uses an algorithm to automatically adjust insulin delivery based on glucose levels. It combines an insulin pump with a continuous glucose monitor (CGM) and uses a closed-loop algorithm to adjust insulin doses based on real-time glucose readings. The "hybrid" aspect refers to the fact that the system still requires some user input, such as entering meal information, but the algorithm takes over the majority of insulin dosing decisions.

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 heatwaves period to 14 days after its end

Secondary outcomes

  1. Adherence to advaced hybrid closed-loop

    Time frame: 14 days

    Change in Time of use automatization of advanced hybrid closed-loop (% possible time of use) from the heatwaves period to 14 days after its end

  2. 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 heatwaves period to 14 days after its endfrom the heatwave period to 14 days after its end

  3. 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 heatwaves period to 14 days after its end

  4. 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 heatwaves period to 14 days after its end

  5. 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 heatwaves period to 14 days after its end

  6. Change in Coefficient of variation percentage (CV)

    Time frame: 14 days

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

  7. Change in Glucose management index

    Time frame: 14 days

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

  8. 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 heatwaves period to 14 days after its end

  9. 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 heatwaves period to 14 days after its end

  10. Change in Percentage of time of varibles modes of automatization

    Time frame: 14 days

    Change in Percentage of time of varibles modes of automatization (temporal objective, sleeping mode, exercise mode) from the heatwaves 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 Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems

Acronym: HEAT1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Aug 22, 2024

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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