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New treatment option for Type 1 Diabetes Mellitus
Official title Simultaneous Measurement and Responsive Treatment - Part 2
ClinicalTrials.gov ID: NCT07655076
What this study is testing
- What it's testing
- This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A:
- Males and females ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide...
- Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin...
- Total daily insulin dose (TDD) between 30 and 100 IU. Part B:
You likely can't join if
- (A and B):
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with the team's recommendations.
- Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).
- Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study...
- Severe hypoglycemic episode within one month of admission.
See the full eligibility criteria
- Part A:
- Males and females ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.
- Total daily insulin dose (TDD) between 30 and 100 IU. Part B:
- Males and females ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.
- Totally daily insulin dose (TDD) between 30 and 100 IU.
- (A and B):
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with the team's recommendations.
- Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).
- Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission...
- Severe hypoglycemic episode within one month of admission.
- Severe diabetic ketoacidosis episode within one month of admission.
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids
- Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.
- Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.