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To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes patients | Adult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
| Change in Time below range 1 (TBR1) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult type 1 diabetes patients using AHCL during and after heatwaves in Castilla-La Mancha (Spain).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Mancha-Centro Hospital | Alcázar de San Juan | Ciudad Real | 13600 | Spain | ||
| Santa Barbara Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31177185 | Background | 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. | |
| 34105073 |
| Label | URL |
|---|---|
| Spanish national forecast service | View source |
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Under other researchers request.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 |
| Puertollano |
| Ciudad Real |
| 13500 |
| Spain |
| Valdepeñas General Hospital | Valdepeñas | Ciudad Real | 13300 | Spain |
| Virgen del Prado Hospital | Talavera de la Reina | Toledo | 45600 | Spain |
| Albacete University Hospital | Albacete | 02006 | Spain |
| Ciudad Real General University Hospital | Ciudad Real | 13005 | Spain |
| Virgen de la Luz University Hospital | Cuenca | 16002 | Spain |
| Guadalajara University Hospital | Guadalajara | 19002 | Spain |
| Toledo University Hospital | Toledo | 45007 | Spain |
| 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. |
| 33515577 | 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. |
| 37201805 | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |