Sponsor study identifier
interventional
13
1 country
1
Study Start
February 5, 2021
Actual (reported)Primary Completion
November 2, 2021
Actual (reported)Study Completion
November 2, 2021
Actual (reported)This study will evaluate the safety and effectiveness of how well blood glucose is managed when a participate wears the investigational SteadiSet™ Infusion Set (SteadiSet device) for up to 14 days post-insertion when compared to a Teflon Control infusion set.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2, 2021
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2020
Actual (reported)October 19, 2020
Actual (reported)February 5, 2021
Actual (reported)November 2, 2021
Actual (reported)November 2, 2021
Actual (reported)Days of successful insulin delivery through the SteadiSet™ insulin infusion device versus a commercially available insulin infusion set
Successful insulin delivery period is defined as the days from infusion set insertion to either a removal of the infusion set due to normal use or removal of the infusion set due to set failure. a removal due to normal use or an infusion set failure, defined as: * The occurrence of hyperglycemia (glucose \>250 mg/dL or 14 mmol/L), not responsive to a pump bolus dose where response to the bolus is defined as a fall of at least 50 mg/dL or 2.8 mmol/L in blood glucose within one hour * The occurrence of any hyperglycemic episode (glucose \> 250 mg/dL or 14 mmol/L) not associated with acute intercurrent illness, but with a concurrent ketone level ≥0.6 mmol/L, or * Signs of infection at the infusion site (e.g. erythema or induration \>1 cm in diameter) at the investigator's discretion, or * Occurrence of a non-resolvable insulin pump occlusion alarm signal
up to 14 days
Participants are randomized into the investigational device (SteadiSet™) insulin infusion set group and then switched to a Commercially available infusion set (using a soft Teflon indwelling cannula) group. At the Day of Insertion (Day 0) clinic visit, study participants will insert (under supervision) the investigational infusion set. Upon completion of a wear period (after 14 days or sooner, in the event that infusion set change out has occurred), participants will be asked to insert a new set at home and thus start the next 14-day wear period. After two periods participants will return to the study site to cross over into the last two periods with the Control device infusion set. A total of four infusion sets will be studied in each participant, two Investigational Device infusion sets and two commercially available Teflon infusion sets.
Participants are randomized into the Commercially available insulin infusion set (using a soft Teflon indwelling cannula) group and then switched to Investigative Device infusion set (SteadiSet™) group. At the Day of Insertion (Day 0) clinic visit, study participants will insert (under supervision) the Control infusion set. Upon completion of a wear period (after 14 days or sooner, in the event that infusion set change out has occurred), participants will be asked to insert a new set at home and thus start the next 14-day wear period. After two periods participants will return to the study site to cross over into the last two periods with the Investigational Device infusion set. A total of four infusion sets will be studied in each participant, two Investigational Device infusion sets and two commercially available Teflon infusion sets.
Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula
Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula
Medizinische Universität Graz
Graz, 8036, Austria
Julia Mader, Professor
Medical University of Graz
13 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2020
First Posted
October 19, 2020
Study Start
February 5, 2021
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 2, 2021
Actual (reported)Study Completion
November 2, 2021
Actual (reported)Last Updated
February 11, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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