Clinical trial 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
- The study wants to see how delivering insulin close to a glucose sensor changes the sensor’s readings and to collect data for developing a combined pump‑CGM system.
- Who it's for
- Adults who have type 1 diabetes and need insulin therapy.
- What's involved
- Participants will wear the investigational pump and sensor during short stays at the research center, have frequent blood‑sugar checks and lab tests, and staff will use the sensor data to guide insulin dosing under supervision.
- Time commitment
- Several short, controlled inpatient visits at the clinical research center, with monitoring throughout each visit.
- 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
- 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
- Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months.
- 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
You likely can't join if
- 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.
- Severe diabetic ketoacidosis episode within one month of admission.
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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 is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.