Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 40 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Subjects will be randomly assigned to one of two study groups for 12 weeks---Group 1 will be treated with AP Technology and Group 2 will wear the study CGM and continue to use their current diabetes management strategy (i.e., standard care)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether an artificial pancreas system—an insulin pump and a continuous blood sugar monitor—can improve heart and blood vessel health. It is for adults ages 18–40 with type 1 diabetes. Researchers will see whether steadier blood sugar lowers signs of inflammation and blood vessel problems.
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. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, the investigators will research whether improvements in blood glucose levels and blood glucose variability will in turn decrease biomarkers of inflammation and endothelial dysfunction while improving cardiovascular function.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 18–40, have type 1 diabetes for at least 1 year, and have used insulin for at least 6 months.
- Have an A1c below 10.5% (a measure of average blood sugar), a body mass index of 18–30 (a measure based on height and weight), and blood pressure below 140/90.
- Not be pregnant or breastfeeding. Women who can become pregnant must have a negative pregnancy test. Sexually active women must use birth control; becoming pregnant or planning pregnancy during the study means leaving the study.
- Use insulin dosing rules consistently for meals and high blood sugar. Pump users must have a history of entering this information into their pump.
- Use only personal Humalog or Novolog insulin during the study, with a total dose of at least 10 units per day. Agree not to start other blood sugar medicines.
- Stop using your own continuous blood sugar monitor once you start using the study monitor.
- Have internet access and agree to upload data, including data from before the study. Use a blood sugar meter that allows data downloads, or use a study meter.
- The study doctor must believe you can use all study devices and follow study instructions.
Who can't join
- In the past 12 months: very low blood sugar causing a seizure or passing out, diabetic ketoacidosis (dangerous acid buildup from too little insulin), or a stroke.
- Heart disease, uncontrolled high blood pressure at rest, or a screening heart test showing rhythm problems or poor blood flow. Also excluded: dose changes to medicines affecting blood vessels within 4 weeks before joining.
- A condition that makes the blood sugar monitor hard to use, such as blindness, severe arthritis, or trouble moving; or another condition or medicine the study doctor considers unsafe.
- Use of steroid pills or inhalers, other medicines the study doctor rules out, or any blood sugar medicine other than insulin.
- A bleeding disorder, current treatment for seizures, or low hemoglobin (the blood protein that carries oxygen): below 11 g/dL for women or 12 g/dL for men.
- Current smoking or quitting less than 2 years ago; nerve damage in the limbs; urine protein above 300 mg per g; or diabetes-related eye damage beyond the mild, early stage.
- A past allergic or other bad reaction to regular insulin given into a vein or to a Definity microbubble infusion.
- Being in another clinical trial, unless both study doctors approve or the other study is only a registry that collects information without giving treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Clinical diagnosis, based on World Health Organization criteria, of type 1 diabetes for at least one year 2. Currently using insulin for at least six months 3. Ages 18-≤40 years 4. Hemoglobin A1c \<10.5% 5. Body mass index 18-30 kg/m2 6. Blood pressure \<140/90 mmHg 7. For females, not currently known to be pregnant or breastfeeding 8. 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 potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued 9. 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 information into their pump 10. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 11. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study 12. Current use of a glucometer that is downloadable; or willingness to use a study glucometer 13. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol 14. Willingness to use personal lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study 15. Total daily insulin dose (TDD) at least 10 U/day. 16. Willingness not to start any new non-insulin glucose-lowering agent during the trial Exclusion Criteria: 1. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 2. Diagnosis of diabetic ketoacidosis in the 12 months prior to enrollment 3. Prior diagnosis of cardiac disease (e.g., myocardial infarction, congestive heart failure) 4. Cerebrovascular accident in the 12 months prior to enrollment 5. Uncontrolled resting arterial hypertension 6. Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility) 7. 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 8. Concurrent use of any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and/or sulfonylureas) 9. Hemophilia or any other bleeding disorder 10. Currently being treated for a seizure disorder 11. A medical condition or medication, which in the opinion of the investigator or designee, would put the participant or study at risk 12. Current smokers or those who have quit smoking \<2 years ago 13. Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease 14. 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) 15. History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to IV regular insulin infusion 16. Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine \>300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy 17. 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.) 18. History of hypersensitivity or prior adverse reaction to Definity microbubble infusion 19. Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial
Study sites (1)
VA
- University of Virginia Health System · Charlottesville, VA 22903Lee M Hartline · Study contact · LMH9D@virginia.eduWilliam B Horton, MD · Principal investigatorMore trials in Charlottesville