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Type 1 DiabetesNCT05646017

Effect of Heatwave Over Glycemic Control in Patients With T1D

An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Intermittenly scanned continuous glucose monitoring
Type of treatment
Medical device
How many people
2,701 participants
Where
9 sitesSpain
Study dates
15 Dec 2022to 31 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Younger than 18 years old
  • Not using intermittently scanned continuous glucose monitoring
  • Not having active paired isCGM data from the analyzed periods

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Albacete University Hospital

    Albacete, 02006

  • La Mancha-Centro Hospital

    Alcázar de San Juan, Ciudad Real, 13600

  • Ciudad Real General University Hospital

    Ciudad Real, 13005

  • Virgen de la Luz University Hospital

    Cuenca, 16002

  • Guadalajara University Hospital

    Guadalajara, 19002

  • Santa Barbara Hospital

    Puertollano, Ciudad Real, 13500

  • Virgen del Prado Hospital

    Talavera de la Reina, Toledo, 45600

  • Toledo University Hospital

    Toledo, 45007

  • Valdepeñas General Hospital

    Valdepeñas, Ciudad Real, 13300

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Intermittenly scanned continuous glucose monitoring
Keywords
Diabetes, Type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittenly scanned continuous glucose monitoringDevice

    Also called FreeStyle Libre, isCGM, FSL

    Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre)

Study groups in NCT05646017
Study groupRoleWhat they receive
Type 1 diabetes patientsType 1 diabetes patients using intermittently continuous glucose monitoring during the Spanish greatest heatwave in Castilla-La Mancha (Spain).
Receives: Device: Intermittenly scanned continuous glucose monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 heatwave period to 14 days after its end

    Measured: 14 days

Secondary outcomes (10)

  1. Change in Adherence to Flash 1

    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

    Measured: 14 days

  2. Change in Adherence to Flash 2

    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

    Measured: 14 days

  3. 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 heatwave period to 14 days after its endfrom the heatwave period to 14 days after its end

    Measured: 14 days

  4. Change in Time below range 2 (TBR2)

    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

    Measured: 14 days

  5. Change in Time above range 1 (TAR1)

    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

    Measured: 14 days

  6. 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 heatwave period to 14 days after its end

    Measured: 14 days

  7. Change in Coefficient of variation percentage (CV)

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

    Measured: 14 days

  8. Change in Glucose management index

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

    Measured: 14 days

  9. Change in Time in hypoglycemia

    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

    Measured: 14 days

  10. Change in Hypoglycemia frequency

    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

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2022
  2. Study start15 Dec 2022
  3. Primary completion1 Jan 2023
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05646017
Sponsor's protocol ID
C-566
Status last verified
Feb 2023
First submitted
2 Dec 2022
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Under other researchers request.

Publications

  • 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.

    PubMed 34105073

  • 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.

    PubMed 33515577

  • Xu Z, Tong S, Cheng J, Crooks JL, Xiang H, Li X, Huang C, Hu W. Heatwaves and diabetes in Brisbane, Australia: a population-based retrospective cohort study. Int J Epidemiol. 2019 Aug 1;48(4):1091-1100. doi: 10.1093/ije/dyz048.

    PubMed 30927429

  • 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.

    PubMed 31177185

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Time in range (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05646017, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

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