Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
NCT ID: NCT04741685
Last Updated: 2021-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2021-02-15
2021-06-10
Brief Summary
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Detailed Description
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All clinical variables are gathered from three EMR softwares and two sensor-augmented pumps sotwares.
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A Kruskal-Wallis or a Friedman 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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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SAP with LGS
Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function
TTSX2
Treatment with Tandem T Slim X2 with Basal IQ
MM640G
Treatment with Medtronic Minimed 640G with Smartguard
Interventions
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TTSX2
Treatment with Tandem T Slim X2 with Basal IQ
MM640G
Treatment with Medtronic Minimed 640G with Smartguard
Eligibility Criteria
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Inclusion Criteria
* Treated with TTSX2 or MM640.
Exclusion Criteria
* Serious mental disease.
18 Years
ALL
No
Sponsors
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Castilla-La Mancha Health Service
OTHER
Responsible Party
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Jesús Moreno Fernández
Principal investigator
Locations
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Nuestra Señora de la Candelaria University Hospital
Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain
Badajoz University Hospital
Badajoz, , Spain
Obispo Rafael Torija, St.
Ciudad Real, , Spain
Countries
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References
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Moreno-Fernandez J, Beato-Vibora P, Olvera P, Garcia-Seco JA, Gallego-Gamero F, Herrera MT, Munoz-Rodriguez JR. Real-world outcomes of two different sensor-augmented insulin pumps with predictive low glucose suspend function in type 1 diabetes patients. Diabetes Res Clin Pract. 2021 Nov;181:109093. doi: 10.1016/j.diabres.2021.109093. Epub 2021 Oct 13.
Other Identifiers
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C-380
Identifier Type: -
Identifier Source: org_study_id
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