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

NCT ID: NCT04741685

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAP with LGS

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

TTSX2

Intervention Type DEVICE

Treatment with Tandem T Slim X2 with Basal IQ

MM640G

Intervention Type DEVICE

Treatment with Medtronic Minimed 640G with Smartguard

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TTSX2

Treatment with Tandem T Slim X2 with Basal IQ

Intervention Type DEVICE

MM640G

Treatment with Medtronic Minimed 640G with Smartguard

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 1 diabetes
* Treated with TTSX2 or MM640.

Exclusion Criteria

* Other kind of diabetes.
* Serious mental disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Castilla-La Mancha Health Service

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jesús Moreno Fernández

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nuestra Señora de la Candelaria University Hospital

Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain

Site Status

Badajoz University Hospital

Badajoz, , Spain

Site Status

Obispo Rafael Torija, St.

Ciudad Real, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34653567 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-380

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.