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New treatment option for Type 1 Diabetes
Official title Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05653518
What this study is testing
- What it's testing
- This study will examine the potential cardiovascular effect(s) of artificial pancreas (AP) technology in patients with type 1 diabetes. AP technology is a system of devices that closely mimics the glucose-regulating function of a healthy human pancreas.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Ages 18-≤40 years
- Hemoglobin A1c \<10.5%
- Body mass index 18-30 kg/m2
You likely can't join if
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Diagnosis of diabetic ketoacidosis in the 12 months prior to enrollment
- Prior diagnosis of cardiac disease (e.g., myocardial infarction, congestive heart failure)
- Cerebrovascular accident in the 12 months prior to enrollment
- Uncontrolled resting arterial hypertension
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
See the full eligibility criteria
- Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Ages 18-≤40 years
- Hemoglobin A1c \<10.5%
- Body mass index 18-30 kg/m2
- Blood pressure \<140/90 mmHg
- For females, not currently known to be pregnant or breastfeeding
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing...
- Both pump and MDI users will use insulin parameters such as carbohydrate ratio and correction factors consistently in order to dose insulin for meals or corrections; pump users will have history of entering this...
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study
- Current use of a glucometer that is downloadable; or willingness to use a study glucometer
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use personal lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day.
- Willingness not to start any new non-insulin glucose-lowering agent during the trial
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Diagnosis of diabetic ketoacidosis in the 12 months prior to enrollment
- Prior diagnosis of cardiac disease (e.g., myocardial infarction, congestive heart failure)
- Cerebrovascular accident in the 12 months prior to enrollment
- Uncontrolled resting arterial hypertension
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Concurrent use of any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and/or sulfonylureas)
- Hemophilia or any other bleeding disorder
- Currently being treated for a seizure disorder
- A medical condition or medication, which in the opinion of the investigator or designee, would put the participant or study at risk
- Current smokers or those who have quit smoking \<2 years ago
- Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease
- Any woman with hemoglobin (Hgb) \<11 g/dL or any man with Hgb \<12 g/dL on screening laboratory evaluation (i.e., complete blood count)
- History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to IV regular insulin infusion
- Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine \>300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy
- Unstable (i.e., dose adjustment less than 4 weeks prior to study enrollment) doses of vasoactive medications (e.g., calcium channel blockers, statins, nitrates, alpha-blockers, beta-blockers, ACE inhibitors, etc.)
- History of hypersensitivity or prior adverse reaction to Definity microbubble infusion
- Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-treatment registry trial
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
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 - 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 to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. 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.