Diabetes Mellitus, Type INCT04591925
SteadiSet™ Pilot Study (SteP Study)
A study testing Investigative insulin infusion devcie in people with Diabetes Mellitus, Type I and IDDM, run by Capillary Biomedical, Inc. at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type I, IDDM, Diabetes Mellitus, Insulin-Dependent, 1
- What is being tested?
- Investigative insulin infusion devcie
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 5 Feb 2021to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
- Significant acute or chronic illness, that in the investigator's opinion, might interfere with participant safety or integrity of study results
- Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
- Current participation in another clinical drug or device study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Control Device insulin infusion devcie, Investigative insulin infusion devcie
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Device insulin infusion devcieDevice
Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula
Investigative insulin infusion devcieDevice
Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control Device insulin infusion devcie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 Feb 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capillary Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Mader, Professor, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591925
- Sponsor's protocol ID
- 150-1139-00
- Status last verified
- Feb 2022
- First submitted
- 2 Oct 2020
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04591925
- Acronym / sponsor ID
- 150-1139-00
- Conditions
- Diabetes Mellitus, Type I, IDDM, Diabetes Mellitus, Insulin-Dependent, 1, Type 1 Diabetes, Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Capillary Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula | Experimental | Device: Investigative insulin infusion devcieParticipants 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. |
| Commercially available Insulin Infusion device using a soft Teflon indwelling cannula | Active comparator | Device: Control Device insulin infusion devcieParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Device insulin infusion devcieControl Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula | Device | Commercially available Insulin Infusion device using a soft Teflon indwelling cannula |
| Investigative insulin infusion devcieInvestigative insulin infusion device with coil-reinforced soft polymer indwelling cannula | Device | Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Mader, Professor principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigative insulin infusion devcie in people with Diabetes Mellitus, Type I and IDDM, run by Capillary Biomedical, Inc. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of successful insulin delivery through the SteadiSet™ insulin infusion device versus a commercially available insulin infusion set (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.