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

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: TTSX2; Device: MM640G

• Registration Number: NCT04741685
• Lead Sponsor: Castilla-La Mancha Health Service

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-02-15
• Status Verified: 2021-06
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-10
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Type 1 diabetes
• Treated with TTSX2 or MM640.

Exclusion Criteria

• Other kind of diabetes.
• Serious mental disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAP with LGS	TTSX2	Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function
SAP with LGS	MM640G	Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function

Primary Outcome Measures

Name	Time	Method
TIR	during the procedure	time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose

Secondary Outcome Measures

Name	Time	Method
GMI	during the procedure	Glucose management index
MAGE	during the procedure	Mean amplitude glucose excursions
Hypoglycemia perception 2	during the procedure	Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points.
TBR	during the procedure	time below range (TBR, \<70 mg/dL, \<3.9 mmol/L) of the interstitial glucose
HbA1C	during the procedure	Glycate haemoglobina A1C
DQOL	during the procedure	Diabetes quality of life (EsDQOL questionnary score), 43 questions, each question with a score from 1 to 5, worse score is five points.
TAR	during the procedure	time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose
%CV	14 days	Coefficient of variation percentage of the intersticial glucose
Hypoglycemia perception 1	during the procedure	Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score "R" or "not R", more "R" means worse score.

Trial Locations

Locations (3)

Nuestra Señora de la Candelaria University Hospital; 🇪🇸 Tenerife, Santa Cruz De Tenerife, Spain

Obispo Rafael Torija, St.; 🇪🇸 Ciudad Real, Spain

Badajoz University Hospital; 🇪🇸 Badajoz, Spain