Effect of Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 193
- Locations
- 9
- Primary Endpoint
- Change in time in range
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in time in range
Time Frame: 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 Outcomes
- Change in Coefficient of variation percentage (CV)(14 days)
- Change in Time below range 2 (TBR2)(14 days)
- Change in Time in hypoglycemia(14 days)
- Change in Time below range 1 (TBR1)(14 days)
- Change in Percentage of time of varibles modes of automatization(14 days)
- Change in Time above range 1 (TAR1)(14 days)
- Change in Glucose management index(14 days)
- Change in Percentage of patients attaining the the International Consensus on Time in Range (ICTR) goals(14 days)
- Adherence to advaced hybrid closed-loop(14 days)
- Change in Time above range 2 (TAR2)(14 days)