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

Type 1 Diabetes Clinical Trial

— HEAT1  

Official title:

Effect of Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214780
• Other study ID #: CI
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Castilla-La Mancha Health Service
• Contact: Jesus Moreno-Fernandez, PhD
• Phone: 926278000
• Email: jmorenof[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• advanced hybrid closed-loop
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.

Locations

Country	Name	City	State
Spain	Albacete University Hospital	Albacete
Spain	La Mancha-Centro Hospital	Alcázar De San Juan	Ciudad Real
Spain	Ciudad Real General University Hospital	Ciudad Real
Spain	Virgen de la Luz University Hospital	Cuenca
Spain	Guadalajara University Hospital	Guadalajara
Spain	Santa Barbara Hospital	Puertollano	Ciudad Real
Spain	Virgen del Prado Hospital	Talavera De La Reina	Toledo
Spain	Toledo University Hospital	Toledo
Spain	Valdepeñas General Hospital	Valdepeñas	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

Moreno-Fernandez J, Sastre J, Herranz S, Pines P, Gomez FJ, Quiroga I, Moya AJ, Gonzalvo C, Miralles R, Calderon-Vicente D, Palma M, Gargallo J, Munoz-Rodriguez JR. Effect of the historic Spanish heatwave over glycemic control in adult patients with type 1 diabetes. Sci Total Environ. 2023 Sep 1;889:164045. doi: 10.1016/j.scitotenv.2023.164045. Epub 2023 May 17. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 heatwaves period to 14 days after its end	14 days
Secondary	Adherence to advaced hybrid closed-loop	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	14 days
Secondary	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 heatwaves period to 14 days after its endfrom the heatwave period to 14 days after its end	14 days
Secondary	Change in Time below range 2 (TBR2)	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	14 days
Secondary	Change in Time above range 1 (TAR1)	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	14 days
Secondary	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 heatwaves period to 14 days after its end	14 days
Secondary	Change in Coefficient of variation percentage (CV)	Change in Coefficient of variation percentage of interstitial glucose from the heatwaves period to 14 days after its end	14 days
Secondary	Change in Glucose management index	Change in Glucose management index of interstitial glucose from the heatwaves period to 14 days after its end	14 days
Secondary	Change in Time in hypoglycemia	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	14 days
Secondary	Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals	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	14 days
Secondary	Change in Percentage of time of varibles modes of automatization	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	14 days

External Links

•   Spanish national forecast service