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

NCT06214780 | Completed

• 1 other identifier: CI
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

advanced hybrid closed-loop; artificial pancreas; heatwave; climate change; global warming

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 heatwaves period to 14 days after its end

  14 days

Secondary Outcomes (10)

• Adherence to advaced hybrid closed-loop

  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

• Change in Time above range 2 (TAR2)

  14 days

Study Arms (1)

Type 1 diabetes patients

Adult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023.

Device: advanced hybrid closed-loop

Interventions

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.

Type 1 diabetes patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult type 1 diabetes patients using AHCL during and after heatwaves in Castilla-La Mancha (Spain).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (9)

La Mancha-Centro Hospital

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Santa Barbara Hospital

Puertollano, Ciudad Real, 13500, Spain

Location

Valdepeñas General Hospital

Valdepeñas, Ciudad Real, 13300, Spain

Location

Virgen del Prado Hospital

Talavera de la Reina, Toledo, 45600, Spain

Location

Albacete University Hospital

Albacete, 02006, Spain

Location

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

Location

Virgen de la Luz University Hospital

Cuenca, 16002, Spain

Location

Guadalajara University Hospital

Guadalajara, 19002, Spain

Location

Toledo University Hospital

Toledo, 45007, Spain

Location

Related 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.

  PMID: 31177185 BACKGROUND

• 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: 34105073 BACKGROUND

• 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.

  PMID: 33515577 BACKGROUND

• 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.

  PMID: 37201805 BACKGROUND

Related Links

• Spanish national forecast service

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 22, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)