Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function
1 other identifier
observational
23
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2021
CompletedJune 11, 2021
June 1, 2021
4 months
January 29, 2021
June 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
TIR
time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose
during the procedure
Secondary Outcomes (9)
TBR
during the procedure
TAR
during the procedure
HbA1C
during the procedure
GMI
during the procedure
MAGE
during the procedure
- +4 more secondary outcomes
Study Arms (1)
SAP with LGS
Type 1 diabetes adults patients treated with sensor-augmented insulin pump with low glucose predictive suspension function
Interventions
Eligibility Criteria
Type 1 diabetes adult patients treated with sensor-augmented pump (TTSX2 or MM640G)
You may qualify if:
- Type 1 diabetes
- Treated with TTSX2 or MM640.
You may not qualify if:
- Other kind of diabetes.
- Serious mental disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Nuestra Señora de la Candelaria University Hospital
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38010, Spain
Badajoz University Hospital
Badajoz, 06080, Spain
Obispo Rafael Torija, St.
Ciudad Real, 13005, Spain
Related Publications (1)
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.
PMID: 34653567DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 5, 2021
Study Start
February 15, 2021
Primary Completion
June 1, 2021
Study Completion
June 10, 2021
Last Updated
June 11, 2021
Record last verified: 2021-06