Type 1 Diabetes
Conditions
Keywords
advanced hybrid closed-loop, artificial pancreas, heatwave, climate change, global warming
Brief summary
To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas
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.
Interventions
DEVICEadvanced 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.
Sponsors
Castilla-La Mancha Health Service
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in range | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time below range 1 (TBR1) | 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 |
| Change in Time below range 2 (TBR2) | 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 |
| Change in Time above range 1 (TAR1) | 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 |
| Change in Time above range 2 (TAR2) | 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 |
| Adherence to advaced hybrid closed-loop | 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 |
| Change in Glucose management index | 14 days | Change in Glucose management index of interstitial glucose from the heatwaves period to 14 days after its end |
| Change in Time in hypoglycemia | 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 |
| Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals | 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 |
| Change in Percentage of time of varibles modes of automatization | 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 |
| Change in Coefficient of variation percentage (CV) | 14 days | Change in Coefficient of variation percentage of interstitial glucose from the heatwaves period to 14 days after its end |
Countries
Spain
Outcome results
None listed