Effect of Heatwave Over Glycemic Control in Patients With T1D

February 7, 2023 updated by: Castilla-La Mancha Health Service

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2701

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult type 1 diabetes patients using intermittently scanned continuous glucose monitoring during and after the greatest Spanish heatwave.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Type 1 diabetes patients
Type 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain).
Device: Intermittenly scanned continuous glucose monitoring
Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)
Other Names:
  • FreeStyle Libre
  • isCGM
  • FSL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 heatwave period to 14 days after its end
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
14 days
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
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 heatwave 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 heatwave 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 heatwave 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 heatwave 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 heatwave 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 heatwave 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 heatwave period to 14 days after its end
14 days
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
14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-566

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

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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