SteadiSet™ Pilot Study (SteP Study)

NCT04591925 | Terminated FDA Device

• 1 other identifier: 150-1139-00
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula

EXPERIMENTAL

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

Commercially available Insulin Infusion device using a soft Teflon indwelling cannula

ACTIVE COMPARATOR

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

Interventions

Control Device insulin infusion devcie DEVICE

Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula

Commercially available Insulin Infusion device using a soft Teflon indwelling cannula

Investigative insulin infusion devcie DEVICE

Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula

Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are 18 - 70 years of age, both inclusive
• Participant is in generally good health, as determined by the investigator
• Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
• Participant must be geographically stable (e.g., expects to be available and capable of returning for all study specified test and examinations) during the study period
• Participant has been diagnosed with T1DM for at least 12 months
• C-peptide \<0.6 nmol/L at screening
• Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
• Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg/dL (14 mmol/L) using a ketone meter and strips provided by the sponsor
• Participant has BMI in the range 18 - 35 kg/m2, both inclusive
• Participant has experience infusing insulin lispro or aspart for at least 6 months
• Participant has been using an insulin pump with commercially available infusion sets for at least 6 months
• Participant shows willingness to use CGM and successfully completes at least 1 week of successful trial with the Dexcom G6 (readings for at least 80% of the time can be retrieved)
• Participant has ability to understand and comply with protocol procedures and to provide informed consent

You may not qualify if:

• Participants routinely using steel insulin infusion sets who due to medical/skin conditions cannot switch to a Teflon set in the control ar
• Participants whose average total daily insulin dose exceeds 85 units/day (i.e. typically change insulin reservoirs more often than every 3.5 days on average
• Participants using any other medication than insulin to control their diabetes
• Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time \> 3.5 days)
• Female participant is pregnant, planning to become pregnant, not using adequate method of contraception or nursing
• Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
• Participant has HbA1C \> 9.0% at screening
• Participant has documented history in last 6 months of severe hypoglycemia associated with cognitive dysfunction sufficiently severe to require third party intervention or a history of impaired awareness of hypoglycemia.
• Participant has a history of diabetic ketoacidosis in the last 6 months
• Participant has known cardiovascular disease considered to be clinically relevant by the investigator
• Participant has known arrhythmias considered to be clinically relevant by the investigator
• Participant has known history of: Cushing's Disease, pancreatic islet cell tumor, or insulinoma
• Participant has: Lipodystrophy, extensive lipohypertrophy, as assessed by the investigator
• Participant is undergoing current treatment with: Systemic oral or intravenous corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, thyroid hormones, unless use has been stable during the past 3 months
• Participant has significant history of any of the following, that in the opinion of the investigator would compromise the participant's safety or successful study participation: Alcoholism, drug abuse

Sponsors & Collaborators

• Capillary Biomedical, Inc.: lead

Study Sites (1)

Medizinische Universität Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Julia Mader, Professor

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: February 5, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

AU (1)