Trials / Completed
CompletedNCT04741685
Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 23 (actual)
- Sponsor
- Castilla-La Mancha Health Service · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TTSX2 | Treatment with Tandem T Slim X2 with Basal IQ |
| DEVICE | MM640G | Treatment with Medtronic Minimed 640G with Smartguard |
Timeline
- Start date
- 2021-02-15
- Primary completion
- 2021-06-01
- Completion
- 2021-06-10
- First posted
- 2021-02-05
- Last updated
- 2021-06-11
Locations
3 sites across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04741685. Inclusion in this directory is not an endorsement.