Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function

Castilla-La Mancha Health Service

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: TTSX2; Device: MM640G

Study type: Observational

Funder types: Other

Identifiers

NCT04741685

C-380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Treated with TTSX2 or MM640.

Exclusion criteria

• Other kind of diabetes.
• Serious mental disease.

Trial design

23 participants in 1 patient group

SAP with LGS

Description:

Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function

Treatment:

Device: MM640G

Device: TTSX2