RECRUITING

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Conditions

Type 1 Diabetes Glycemic Variability Inflammation Oxidative Stress Endothelial Function Myocardial Perfusion Aortic Stiffness Flow-Mediated Dilation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes

Quick Facts

Study Start:2023-09-09

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05653518

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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. 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) 13. Current smokers or those who have quit smoking \<2 years ago 14. Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease 15. Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine \>300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy 16. 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.) 17. History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to regular insulin infusion 18. Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial 19. History of hypersensitivity or prior adverse reaction to Definity microbubble infusion

Inclusion Criteria

Exclusion 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

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. 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)
13. Current smokers or those who have quit smoking \<2 years ago
14. Screening Electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease
15. Diagnosis of peripheral neuropathy (assessed by monofilament examination), macroalbuminuria (urine albumin:creatinine \>300 mg per g), or retinopathy beyond mild, nonproliferative retinopathy
16. 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.)
17. History of hypersensitivity or prior adverse reaction (e.g., anaphylaxis or angioedema) to regular insulin infusion
18. Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial
19. History of hypersensitivity or prior adverse reaction to Definity microbubble infusion

Contacts and Locations

Study Contact

William B Horton, MD

CONTACT

434-924-1828

WBH2N@uvahealth.org

Lee Hartline, MEd

CONTACT

434-924-5247

lmh9d@virginia.edu

Principal Investigator

William B Horton, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia Health System

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

William B Horton, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-09

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2023-09-09

Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

Glycemic Variability
Inflammation
Oxidative Stress
Endothelial Function
Myocardial Perfusion
Aortic Stiffness
Flow-Mediated Dilation

Additional Relevant MeSH Terms

Type 1 Diabetes