Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas
- Conditions
- Type 1 Diabetes
- Interventions
- Device: advanced hybrid closed-loop
- Registration Number
- NCT06214780
- Lead Sponsor
- Castilla-La Mancha Health Service
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
- 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
- Younger than 18 years old
- Not using AHCL
- Not having active paired AHCL data from the analyzed periods
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Type 1 diabetes patients advanced hybrid closed-loop Adult patients treated with advanced hybrid closed-loop in Castilla-La Mancha during summer 2023.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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 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 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 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 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 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
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 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
Trial Locations
- Locations (9)
Virgen del Prado Hospital
🇪🇸Talavera De La Reina, Toledo, Spain
Albacete University Hospital
🇪🇸Albacete, Spain
Guadalajara University Hospital
🇪🇸Guadalajara, Spain
Ciudad Real General University Hospital
🇪🇸Ciudad Real, Spain
Virgen de la Luz University Hospital
🇪🇸Cuenca, Spain
Toledo University Hospital
🇪🇸Toledo, Spain
Valdepeñas General Hospital
🇪🇸Valdepeñas, Ciudad Real, Spain
La Mancha-Centro Hospital
🇪🇸Alcázar De San Juan, Ciudad Real, Spain
Santa Barbara Hospital
🇪🇸Puertollano, Ciudad Real, Spain