Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214780
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2024-01-10
Brief Title:
Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas
Sponsor:
Castilla-La Mancha Health Service
Organization:
Castilla-La Mancha Health Service
Study Overview
Official Title:
Effect of Heatwaves on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus Treated With Advanced Hybrid Closed Loop Systems
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAT1
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 30-10 mmolL 70-180 mgd 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 Students 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 005 was considered statistically significant The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None