An observational study in Type 1 Diabetes, sponsored by Castilla-La Mancha Health Service. Completed at 25 sites in Spain. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Castilla-La Mancha Health Service · Observational
Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.
Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.
All clinical variables are gathered from the Spanish Insulin Pump National Registry.
Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. 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. All participants provided written informed consent.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 2,977 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Castilla-La Mancha Health Service is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.
Exclusion Criteria:
All patient treated with insulin pump.
Device: Insulin pump
Treatment with continuous subcutaneous insulin infusion
HbA1C
Glycated haemoglobin A1C
Time frame: During the procedure
TIR
Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose
Time frame: During the procedure
TAR
Time above range (TAR, \>10 mmol/L, \>180 mg/dL) of the interstitial glucose
Time frame: During the procedure
TUR
Time under range (TUR, \<3.9 mmol/L, \<70 mg/dL) of the interstitial glucose
Time frame: During the procedure
Clinical significant hypoglycemia
Time in clinical significant hypoglycemia (\< 3 mmol/L, \<54 mg/dL) of the interstitial glucose
Time frame: During the procedure
MIG
Mean interstitial glucose (mmol/L, mg/dL)
Time frame: During the procedure
%CV
Percentage of the variation coefficient (%, \>36% is considered high levels)
Time frame: During the procedure
Adherence to CGM
Time of use of continuous glucose monitoring (% possible time of use)
Time frame: During the procedure
Weight
Total corporal weight (Kg)
Time frame: During the procedure
Insulin dose
Daily insulin dose requirements (UI/Kg/d)
Time frame: During the procedure
DKA
Number of diabetic ketoacidosis (number of events)
Time frame: During the procedure
Severe hypoglycemia
Number of severe hypoglycemia (number of events)
Time frame: During the procedure
Hospital admission
Number of hospital admission due to insulin pump (number of events)
Time frame: During the procedure
Plan to share: Undecided — IPD will be available after studying each request.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Castilla-La Mancha Health Service