Type 1 DiabetesWBH002NCT05653518
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
A study testing Sensor augmented pump (SAP) therapy in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sensor augmented pump (SAP) therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2023to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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 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
- 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
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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-interventional registry trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
Lee M Hartline, LMH9D@virginia.edu
William B Horton, MD
About this study
Official title: Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes
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.
Read the detailed description
Cardiovascular disease is a type of disease that affects the heart and blood vessels. The current care for cardiovascular disease prevention in people with type 1 diabetes is to manage blood pressure, cholesterol blood levels, or manage blood glucose levels.
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, we will use the Food and Drug Administration (FDA)-approved Tandem t:slim insulin pump with Control-IQ Technology and the FDA approved Dexcom G6 CGM. This study will research whether improvements in blood glucose metrics lead to reductions in some of the cardiovascular biomarkers that represent harmful effects in people with type 1 diabetes. 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).
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem t:slim X2 with Control-IQ Technology, Sensor augmented pump (SAP) therapy
- Keywords
- Glycemic Variability, Inflammation, Oxidative Stress, Endothelial Function, Myocardial Perfusion, Aortic Stiffness, Flow-Mediated Dilation
- Medical subject headings
- Diabetes Mellitus, Type 1, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem t:slim X2 with Control-IQ TechnologyDevice
FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM
Sensor augmented pump (SAP) therapyDevice
Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop artificial pancreas (AP) | Experimental | FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM Receives: Device: Tandem t:slim X2 with Control-IQ Technology |
| Sensor Augmented Pump (SAP) therapy | Experimental | Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's current insulin therapy (i.e., either insulin pump or multiple daily injections) Receives: Device: Sensor augmented pump (SAP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Time-in-Range
Time-in-range will measured by continuous glucose monitor device
Measured: 12 weeks
Secondary outcomes (9)
High-sensitivity C-reactive protein (hs-CRP)
Inflammatory Biomarker
Measured: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
TNF-alpha
Inflammatory Biomarker
Measured: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Interleukin-6 (IL-6)
Inflammatory Biomarker
Measured: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
E-selectin
Biomarker of endothelial dysfunction
Measured: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Intracellular adhesion molecule 1 (ICAM-1)
Biomarker of endothelial dysfunction
Measured: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Myocardial Perfusion (measured by contrast-enhanced ultrasound [CEU])
CEU will be assessed before and during a euglycemic-hyperinsulinemic clamp
Measured: At baseline and 12 weeks of treatment
Carotid Femoral Pulse Wave Velocity (cfPWV)
Measurement of change in central aortic stiffness
Measured: At baseline and 12 weeks of treatment
Brachial artery flow-mediated dilation (FMD)
Measure of conduit artery endothelial function
Measured: At baseline and 12 weeks of treatment
Insulin sensitivity
insulin sensitivity will be assessed by M value during a euglycemic-hyperinsulinemic clamp
Measured: At baseline and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start9 Sep 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Horton, MD, University of Virginia
- Investigators
- William B Horton, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653518
- Sponsor's protocol ID
- 220180
- Other IDs
- 941481, 3-SRA-2023-1236-M-B
- Acronym
- WBH002
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Livingstone SJ, Looker HC, Hothersall EJ, Wild SH, Lindsay RS, Chalmers J, Cleland S, Leese GP, McKnight J, Morris AD, Pearson DW, Peden NR, Petrie JR, Philip S, Sattar N, Sullivan F, Colhoun HM. Risk of cardiovascular disease and total mortality in adults with type 1 diabetes: Scottish registry linkage study. PLoS Med. 2012;9(10):e1001321. doi: 10.1371/journal.pmed.1001321. Epub 2012 Oct 2.
PubMed 23055834Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
PubMed 20739685Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
PubMed 25126392Priya G, Kalra S. A Review of Insulin Resistance in Type 1 Diabetes: Is There a Place for Adjunctive Metformin? Diabetes Ther. 2018 Feb;9(1):349-361. doi: 10.1007/s13300-017-0333-9. Epub 2017 Nov 14.
PubMed 29139080Alessa T, Szeto A, Chacra W, Mendez A, Goldberg RB. High HDL-C prevalence is common in type 1 diabetes and increases with age but is lower in Hispanic individuals. J Diabetes Complications. 2015 Jan-Feb;29(1):105-7. doi: 10.1016/j.jdiacomp.2014.08.011. Epub 2014 Sep 6.
PubMed 25441221Norgaard K, Feldt-Rasmussen B, Borch-Johnsen K, Saelan H, Deckert T. Prevalence of hypertension in type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1990 Jul;33(7):407-10. doi: 10.1007/BF00404089.
PubMed 2401396Corbin KD, Driscoll KA, Pratley RE, Smith SR, Maahs DM, Mayer-Davis EJ; Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON). Obesity in Type 1 Diabetes: Pathophysiology, Clinical Impact, and Mechanisms. Endocr Rev. 2018 Oct 1;39(5):629-663. doi: 10.1210/er.2017-00191.
PubMed 30060120Kanter JE, Shao B, Kramer F, Barnhart S, Shimizu-Albergine M, Vaisar T, Graham MJ, Crooke RM, Manuel CR, Haeusler RA, Mar D, Bomsztyk K, Hokanson JE, Kinney GL, Snell-Bergeon JK, Heinecke JW, Bornfeldt KE. Increased apolipoprotein C3 drives cardiovascular risk in type 1 diabetes. J Clin Invest. 2019 Jul 11;129(10):4165-4179. doi: 10.1172/JCI127308.
PubMed 31295146Risso A, Mercuri F, Quagliaro L, Damante G, Ceriello A. Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture. Am J Physiol Endocrinol Metab. 2001 Nov;281(5):E924-30. doi: 10.1152/ajpendo.2001.281.5.E924.
PubMed 11595647Quagliaro L, Piconi L, Assaloni R, Martinelli L, Motz E, Ceriello A. Intermittent high glucose enhances apoptosis related to oxidative stress in human umbilical vein endothelial cells: the role of protein kinase C and NAD(P)H-oxidase activation. Diabetes. 2003 Nov;52(11):2795-804. doi: 10.2337/diabetes.52.11.2795.
PubMed 14578299Piconi L, Quagliaro L, Assaloni R, Da Ros R, Maier A, Zuodar G, Ceriello A. Constant and intermittent high glucose enhances endothelial cell apoptosis through mitochondrial superoxide overproduction. Diabetes Metab Res Rev. 2006 May-Jun;22(3):198-203. doi: 10.1002/dmrr.613.
PubMed 16453381Horvath EM, Benko R, Kiss L, Muranyi M, Pek T, Fekete K, Barany T, Somlai A, Csordas A, Szabo C. Rapid 'glycaemic swings' induce nitrosative stress, activate poly(ADP-ribose) polymerase and impair endothelial function in a rat model of diabetes mellitus. Diabetologia. 2009 May;52(5):952-61. doi: 10.1007/s00125-009-1304-0. Epub 2009 Mar 5.
PubMed 19263033Frontoni S, Di Bartolo P, Avogaro A, Bosi E, Paolisso G, Ceriello A. Glucose variability: An emerging target for the treatment of diabetes mellitus. Diabetes Res Clin Pract. 2013 Nov;102(2):86-95. doi: 10.1016/j.diabres.2013.09.007. Epub 2013 Sep 25.
PubMed 24128999Ayano-Takahara S, Ikeda K, Fujimoto S, Hamasaki A, Harashima S, Toyoda K, Fujita Y, Nagashima K, Tanaka D, Inagaki N. Glycemic variability is associated with quality of life and treatment satisfaction in patients with type 1 diabetes. Diabetes Care. 2015 Jan;38(1):e1-2. doi: 10.2337/dc14-1801. No abstract available.
PubMed 25538320FLAT-SUGAR Trial Investigators. Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk. Diabetes Care. 2016 Jun;39(6):973-81. doi: 10.2337/dc15-2782. Epub 2016 Apr 19.
PubMed 27208320
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05653518
- Acronym / sponsor ID
- WBH002 / 220180
- Conditions
- Type 1 Diabetes
- Keywords
- Glycemic Variability, Inflammation, Oxidative Stress, Endothelial Function, Myocardial Perfusion, Aortic Stiffness, Flow-Mediated Dilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease is a type of disease that affects the heart and blood vessels. The current care for cardiovascular disease prevention in people with type 1 diabetes is to manage blood pressure, cholesterol blood levels, or manage blood glucose levels.
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, we will use the Food and Drug Administration (FDA)-approved Tandem t:slim insulin pump with Control-IQ Technology and the FDA approved Dexcom G6 CGM. This study will research whether improvements in blood glucose metrics lead to reductions in some of the cardiovascular biomarkers that represent harmful effects in people with type 1 diabetes. 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop artificial pancreas (AP) | Experimental | Device: Tandem t:slim X2 with Control-IQ TechnologyFDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM |
| Sensor Augmented Pump (SAP) therapy | Experimental | Device: Sensor augmented pump (SAP) therapySensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's current insulin therapy (i.e., either insulin pump or multiple daily injections) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem t:slim X2 with Control-IQ TechnologyFDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM | Device | Closed-loop artificial pancreas (AP) |
| Sensor augmented pump (SAP) therapySensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's personal insulin pump | Device | Sensor Augmented Pump (SAP) therapy |
Primary outcome
Glucose Time-in-Range
Time frame: 12 weeks
Time-in-range will measured by continuous glucose monitor device
9 secondary outcomes
High-sensitivity C-reactive protein (hs-CRP)
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
TNF-alpha
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Interleukin-6 (IL-6)
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
E-selectin
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Intracellular adhesion molecule 1 (ICAM-1)
Time frame: At baseline (0 weeks), 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Myocardial Perfusion (measured by contrast-enhanced ultrasound [CEU])
Time frame: At baseline and 12 weeks of treatment
Carotid Femoral Pulse Wave Velocity (cfPWV)
Time frame: At baseline and 12 weeks of treatment
Brachial artery flow-mediated dilation (FMD)
Time frame: At baseline and 12 weeks of treatment
Insulin sensitivity
Time frame: At baseline and 12 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 23055834Livingstone SJ, Looker HC, Hothersall EJ, Wild SH, Lindsay RS, Chalmers J, Cleland S, Leese GP, McKnight J, Morris AD, Pearson DW, Peden NR, Petrie JR, Philip S, Sattar N, Sullivan F, Colhoun HM. Risk of cardiovascular disease and total mortality in adults with type 1 diabetes: Scottish registry linkage study. PLoS Med. 2012;9(10):e1001321. doi: 10.1371/journal.pmed.1001321. Epub 2012 Oct 2.
- Background: PubMed 20739685Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
- Background: PubMed 25126392Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
- Background: PubMed 29139080Priya G, Kalra S. A Review of Insulin Resistance in Type 1 Diabetes: Is There a Place for Adjunctive Metformin? Diabetes Ther. 2018 Feb;9(1):349-361. doi: 10.1007/s13300-017-0333-9. Epub 2017 Nov 14.
- Background: PubMed 25441221Alessa T, Szeto A, Chacra W, Mendez A, Goldberg RB. High HDL-C prevalence is common in type 1 diabetes and increases with age but is lower in Hispanic individuals. J Diabetes Complications. 2015 Jan-Feb;29(1):105-7. doi: 10.1016/j.jdiacomp.2014.08.011. Epub 2014 Sep 6.
- Background: PubMed 2401396Norgaard K, Feldt-Rasmussen B, Borch-Johnsen K, Saelan H, Deckert T. Prevalence of hypertension in type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1990 Jul;33(7):407-10. doi: 10.1007/BF00404089.
- Background: PubMed 30060120Corbin KD, Driscoll KA, Pratley RE, Smith SR, Maahs DM, Mayer-Davis EJ; Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON). Obesity in Type 1 Diabetes: Pathophysiology, Clinical Impact, and Mechanisms. Endocr Rev. 2018 Oct 1;39(5):629-663. doi: 10.1210/er.2017-00191.
- Background: PubMed 31295146Kanter JE, Shao B, Kramer F, Barnhart S, Shimizu-Albergine M, Vaisar T, Graham MJ, Crooke RM, Manuel CR, Haeusler RA, Mar D, Bomsztyk K, Hokanson JE, Kinney GL, Snell-Bergeon JK, Heinecke JW, Bornfeldt KE. Increased apolipoprotein C3 drives cardiovascular risk in type 1 diabetes. J Clin Invest. 2019 Jul 11;129(10):4165-4179. doi: 10.1172/JCI127308.
- Background: PubMed 11595647Risso A, Mercuri F, Quagliaro L, Damante G, Ceriello A. Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture. Am J Physiol Endocrinol Metab. 2001 Nov;281(5):E924-30. doi: 10.1152/ajpendo.2001.281.5.E924.
- Background: PubMed 14578299Quagliaro L, Piconi L, Assaloni R, Martinelli L, Motz E, Ceriello A. Intermittent high glucose enhances apoptosis related to oxidative stress in human umbilical vein endothelial cells: the role of protein kinase C and NAD(P)H-oxidase activation. Diabetes. 2003 Nov;52(11):2795-804. doi: 10.2337/diabetes.52.11.2795.
- Background: PubMed 16453381Piconi L, Quagliaro L, Assaloni R, Da Ros R, Maier A, Zuodar G, Ceriello A. Constant and intermittent high glucose enhances endothelial cell apoptosis through mitochondrial superoxide overproduction. Diabetes Metab Res Rev. 2006 May-Jun;22(3):198-203. doi: 10.1002/dmrr.613.
- Background: PubMed 19263033Horvath EM, Benko R, Kiss L, Muranyi M, Pek T, Fekete K, Barany T, Somlai A, Csordas A, Szabo C. Rapid 'glycaemic swings' induce nitrosative stress, activate poly(ADP-ribose) polymerase and impair endothelial function in a rat model of diabetes mellitus. Diabetologia. 2009 May;52(5):952-61. doi: 10.1007/s00125-009-1304-0. Epub 2009 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William B Horton, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor augmented pump (SAP) therapy in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William B Horton, MD (434-924-1828, WBH2N@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Time-in-Range (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653518, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.