NCT04591925

SteadiSet™ Pilot Study (SteP Study)

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Capillary Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type I
• IDDM
• Diabetes Mellitus, Insulin-Dependent, 1
• Type 1 Diabetes
• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Control Device insulin infusion devcie	Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula
DEVICE	Investigative insulin infusion devcie	Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula

Timeline

• Start date: 2021-02-05
• Primary completion: 2021-11-02
• Completion: 2021-11-02
• First posted: 2020-10-19
• Last updated: 2022-02-11

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study