Clinical trial NCT04741685: Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
Official title: Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Castilla-La Mancha Health Service
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)

Brief summary: Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.

Detailed description: Cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, Tandem T Slim X2 with Basal IQ (TTSX2) and Medtronic Minimed 640G with Smartguard (MM640G) in adult patients with type 1 Diabetes mellitus.

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.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Treated with TTSX2 or MM640.

Exclusion Criteria:

* Other kind of diabetes.
* Serious mental disease.

Primary outcomes:
measure: TIR
timeFrame: during the procedure
Secondary outcomes:
measure: TBR
timeFrame: during the procedure
measure: TAR
timeFrame: during the procedure
measure: HbA1C
timeFrame: during the procedure
measure: GMI
timeFrame: during the procedure
measure: MAGE
timeFrame: during the procedure
measure: %CV
timeFrame: 14 days
measure: DQOL
timeFrame: during the procedure
measure: Hypoglycemia perception 1
timeFrame: during the procedure
measure: Hypoglycemia perception 2
timeFrame: during the procedure
Other outcomes:
Locations:
city: Tenerife
country: Spain
facility: Nuestra Señora de la Candelaria University Hospital
state: Santa Cruz De Tenerife
city: Badajoz
country: Spain
facility: Badajoz University Hospital
city: Ciudad Real
country: Spain
facility: Obispo Rafael Torija, St.
Study officials:
References:
citation: 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.