Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas (HEAT1)

August 21, 2024 updated by: Castilla-La Mancha Health Service

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Albacete University Hospital
      • Ciudad Real, Spain, 13005
        • Ciudad Real General University Hospital
      • Cuenca, Spain, 16002
        • Virgen de la Luz University Hospital
      • Guadalajara, Spain, 19002
        • Guadalajara University Hospital
      • Toledo, Spain, 45007
        • Toledo University Hospital
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain, 13600
        • La Mancha-Centro Hospital
      • Puertollano, Ciudad Real, Spain, 13500
        • Santa Barbara Hospital
      • Valdepeñas, Ciudad Real, Spain, 13300
        • Valdepeñas General Hospital
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Virgen del Prado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 diabetes patients
Adult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Under other researchers request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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