AzTrials
AzTrials

Type 1 DiabetesHEAT1NCT06214780

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

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
Search all trials

Trial summary

To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas 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?
advanced hybrid closed-loop
Type of treatment
Medical device
How many people
193 participants
Where
9 sitesSpain
Study dates
22 Jan 2024to 31 May 2024
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
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Younger than 18 years old
  • Not using AHCL
  • Not having active paired AHCL 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 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

Read the 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.

Conditions
Type 1 Diabetes
Being tested
advanced hybrid closed-loop
Keywords
advanced hybrid closed-loop, artificial pancreas, heatwave, climate change, global warming
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • advanced hybrid closed-loopDevice

    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.

Study groups in NCT06214780
Study groupRoleWhat they receive
Type 1 diabetes patientsAdult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023.
Receives: Device: advanced hybrid closed-loop

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 heatwaves period to 14 days after its end

    Measured: 14 days

Secondary outcomes (10)

  1. 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

    Measured: 14 days

  2. 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

    Measured: 14 days

  3. 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

    Measured: 14 days

  4. 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

    Measured: 14 days

  5. 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

    Measured: 14 days

  6. 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

    Measured: 14 days

  7. Change in Glucose management index

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

    Measured: 14 days

  8. 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

    Measured: 14 days

  9. 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

    Measured: 14 days

  10. 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

    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 posted22 Jan 2024
  2. Study start22 Jan 2024
  3. Primary completion30 Apr 2024
  4. Study completion31 May 2024

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
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214780
Sponsor's protocol ID
CI
Acronym
HEAT1
Status last verified
Aug 2024
First submitted
10 Jan 2024
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Under other researchers request.

Publications

  • 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

  • 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

  • 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.

    PubMed 37201805

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 22 Aug 2024. 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 NCT06214780, 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 22 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in