SteadiSet™ Pilot Study (SteP Study)
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|ClinicalTrials.gov Identifier: NCT04591925|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type I IDDM Diabetes Mellitus, Insulin-Dependent, 1 Type 1 Diabetes Type 1 Diabetes Mellitus||Device: Control Device insulin infusion devcie Device: Investigative insulin infusion devcie||Not Applicable|
Up to 48 adult participants, ages 18-70, diagnosed with type 1 diabetes mellitus (T1DM) may be enrolled, aiming for approximately 40 completers. Participants must have ≥6 months experience using a rapid-acting insulin analog delivered via tubing-based insulin pumps and infusion sets and must demonstrate willingness and ability to use a continuous glucose monitor (CGM). Study participants will be drawn from existing T1DM patient populations meeting the study eligibility at the study center.
Existing patient populations at the study center will be screened for study eligibility within 21 days of planned study randomization. Eligible participants will complete written informed consent and will be assigned a unique study ID. Enrolled participants will complete a one-week run-in period to assess participant compliance to collect adequate CGM data (>80% of possible readings) with the study CGM. Participants who do not achieve this goal will be given a second week of CGM data collection; failing the second week of adequate data collection they will be discontinued from study.
At the Day of Insertion (Day 0) clinic visit, study participants will be randomized to insert (under supervision) either an investigational SteadiSet or a commercially-available Teflon infusion set (different to their routine set); an automatic insertion device will be used for all infusion set insertion procedures during study. Participants will undergo training and be provided written instructions if infusion set failure occurs and set change is required during the up to 14-day wear period. Visual inspection and photographic documentation of the infusion set insertion site will be recorded at Day 0. Participants will be asked to conduct daily insertion site visual inspection and report/record site reactions, unexplained hypo- and hyperglycemic events and symptoms and/or the need for infusion set change (Days +1 to +14).
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 respective other infusion set (SteadiSet or Control device, self-insertion under supervision). A total of four infusion sets will be studied in each participant, two SteadiSet and two commercially available Teflon infusion sets.
Insulin therapy will be performed by the participants using their own insulin pump as under routine conditions. Participants will continue to use the rapid acting insulin analog they also use under routine conditions (insulins aspart or lispro). Insulin reservoir and tubing change will be performed as under routine conditions every 6 (insulin aspart) or 7 (insulin lispro) days (or sooner for participants who use more than 300 units every 6-7 days). The infusion set will NOT be changed at the time of reservoir change.
Continuous glucose monitoring will be performed throughout the study. At least four-point capillary blood glucose measurements will be performed each day (pre-meal, bed-time). Participants will be asked to perform capillary ketone measurements in case of unexplained hyperglycemia (glucose >250 mg/dL or 14 mmol/L). Unexplained hypo- or hyperglycemia measured by CGM needs to be verified by capillary glucose measurements. Data from the participant's blood glucose and ketone monitor will be downloaded upon completion of each infusion set wear period. The diary will be collected at each study center visit.
End-of-study will occur at the clinic visit following the fourth study period or upon 30-day follow-up of ongoing adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open, Controlled, and Randomized Cross-Over Pilot Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes Mellitus|
|Estimated Study Start Date :||January 30, 2021|
|Estimated Primary Completion Date :||March 26, 2021|
|Estimated Study Completion Date :||March 26, 2021|
Experimental: Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula
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.
Device: Investigative insulin infusion devcie
Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula
Active Comparator: Commercially available Insulin Infusion device using a soft Teflon indwelling cannula
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.
Device: Control Device insulin infusion devcie
Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula
- Days of successful insulin delivery through the SteadiSet™ insulin infusion device versus a commercially available insulin infusion set [ Time Frame: up to 14 days ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591925
|Contact: Study Managerfirstname.lastname@example.org|
|Principal Investigator:||Julia Mader, Professor||Medical University of Graz|
|Principal Investigator:||David O'Neal, MD||University of Melbourne|