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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: TTSX2; Device: MM640G

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06080
    • Badajoz University Hospital
  • Ciudad Real, Spain, 13005
    • Obispo Rafael Torija, St.
  • Santa Cruz De Tenerife
    • Tenerife, Santa Cruz De Tenerife, Spain, 38010
      • Nuestra Señora de la Candelaria University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)

Description

Inclusion Criteria:

• Type 1 diabetes
• Treated with TTSX2 or MM640.

Exclusion Criteria:

• Other kind of diabetes.
• Serious mental disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SAP with LGS; Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function	Device: TTSX2; Treatment with Tandem T Slim X2 with Basal IQ; Device: MM640G; Treatment with Medtronic Minimed 640G with Smartguard

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Castilla-La Mancha Health Service

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: C-380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All clinical data if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes