SteadiSet™ Pilot Study (SteP Study)
Diabetes Mellitus, Type I, IDDM, Diabetes Mellitus, Insulin-Dependent, 1
About this trial
This is an interventional other trial for Diabetes Mellitus, Type I
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Medizinische Universität Graz
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Investigative Device - SteadiSet™" device with coil-reinforced soft polymer indwelling cannula
Commercially available Insulin Infusion device using a soft Teflon 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.
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.