Type 1 DiabetesNCT04878120
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
A study testing Standard HCL System and HCL System with Smart Bolus Calculator in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Standard HCL System and HCL System with Smart Bolus Calculator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥12 and <18 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year
- Currently using insulin for at least six months
- Currently using an insulin pump for at least three months
- Currently using a CGM system for at least three months
- Having at least 75% of CGM data over the previous four weeks
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- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
- For females, not currently known to be pregnant or breastfeeding
- A negative urine pregnancy test will be required for all females of childbearing potential
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) of at least 10 U/day
- Willingness not to start any non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 40 grams of carbohydrates per meal
- An understanding and willingness to follow the protocol and signed informed consent
- Participants and parent/legal guardians will be proficient in reading and writing in English
- Willingness to comply with COVID-19 precautions as defined by the study team
- Having completed a COVID-19 vaccination with an FDA-approved COVID-19 vaccine at least two weeks before the first study admission, and willing to provide a copy of the COVID-19 vaccination card
Who cannot join
- Hemoglobin A1c <5% or >10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL
- History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
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- Planned surgery during study duration
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an insulin delivery mechanism that is not downloadable by the participant or study team
- Known contact with COVID-positive individual within 14 days of any study admission without negative follow-up COVID-19 Polymerase Chain Reaction (PCR) test performed 3-5 days after the date of exposure
- Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission
- A positive COVID-19 test within 14 days of any study admission or during study admission participation
- Not being fully vaccinated at the time of the first camp admission (according to Center for Disease Control (CDC) guidelines a person is intended to be fully vaccinated after two weeks from either the second dose of the Pfizer or Moderna vaccine, or the single dose of the Johnson \& Johnson vaccine)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22902
About this study
Official title: Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.
Read the detailed description
This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - <18 years) with T1D who currently manage their diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.
- Conditions
- Type 1 Diabetes
- Being tested
- Standard HCL System, HCL System with Smart Bolus Calculator
- Keywords
- Insulin Sensitivity (SI), Adolescent, Insulin Pump, Continuous Glucose Monitor (CGM), Hybrid Closed Loop (HCL), Diabetes Camp
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HCL SystemDevice
Standard HCL system (USS Virginia)
HCL System with Smart Bolus CalculatorDevice
HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity
| Study group | Role | What they receive |
|---|---|---|
| Standard HCL System - HCL System with Smart Bolus Calculator | Other | Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity Receives: Device: Standard HCL System; Device: HCL System with Smart Bolus Calculator |
| HCL System with Smart Bolus Calculator - Standard HCL System | Other | Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system Receives: Device: Standard HCL System; Device: HCL System with Smart Bolus Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Blood Glucose Index (LBGI)
LBGI computed from CGM collected in the four hours following the dinner meal.
LBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps:
- Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation: rL(i) = 10 x (1.509 x (log(CGM(i))^1.084 - 5.381))^2, if CGM(i) <=112.5 mg/dL; rL(i) = 0, if CGM(i) >112.5 mg/dL
- Averaging the risk scores rL(i), i=1,...,N.
The hypoglycemia risk score ranges from 0 for CGM readings >112.5 mg/dL (no hypoglycemia risk) to 100 for CGM readings =20 mg/dL (maximum hypoglycemia risk); consequently, LBGI can theoretically assume values between 0 and 100 as well. Clinically relevant LBGI thresholds have been defined:
- LBGI <2.5: low hypoglycemia risk
- LBGI in 2.5-5: moderate hypoglycemia risk
- LBGI >5: high hypoglycemia risk.
Measured: 4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)
Secondary outcomes (6)
Percentage of Time Spent Below 70 mg/dL
Percentage of CGM readings in hypoglycemia below 70 mg/dL
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent in 70-180 mg/dL
Percentage of CGM readings in normoglycemia between 70-180 mg/dL
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent Above 180 mg/dL
Percentage of CGM readings in hyperglycemia above 180 mg/dL
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
High Blood Glucose Index (HBGI)
HBGI computed from CGM collected in the four hours following the dinner meal.
HBGI is a metric quantifying the risk for hyperglycemia (the higher the HBGI, the higher the exposure to/risk of hyperglycemia), calculated based on the following two steps:
- Transforming each CGM reading in the time-series of length N into a hyperglycemia risk score (rH(i), i=1,...,N) by applying the following transformation: rH(i) = 10 x (1.509 x (log(CGM(i))^1.084 - 5.381))^2, if CGM(i) >112.5 mg/dL; rH(i) = 0, if CGM(i) <=112.5 mg/dL
- Averaging the risk scores rH(i), i=1,...,N.
The hyperglycemia risk score ranges from 0 for CGM readings <=112.5 mg/dL (no hyperglycemia risk) to 100 for CGM readings =600 mg/dL (maximum hyperglycemia risk); consequently, HBGI can theoretically assume values between 0 and 100 as well. Clinically relevant HBGI thresholds have been defined:
- HBGI <4.5: low hyperglycemia risk
- HBGI in 4.5-9: moderate hyperglycemia risk
- HBGI >9: high hyperglycemia risk.
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
CGM Coefficient of Variation
CGM coefficient of variation as a measure of glucose variability
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Total Amount of Carbohydrate Administered as Rescue Treatments
Total amount of carbohydrate administered as rescue treatments per study protocol
Measured: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start14 May 2021
- Primary completion24 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Chiara Fabris, PhD, University of Virginia
- Investigators
- Chiara Fabris, PhD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878120
- Sponsor's protocol ID
- 210112
- Other IDs
- 4-CDA-2020-948-A-N
- Status last verified
- May 2024
- First submitted
- 4 May 2021
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04878120
- Acronym / sponsor ID
- 210112
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Sensitivity (SI), Adolescent, Insulin Pump, Continuous Glucose Monitor (CGM), Hybrid Closed Loop (HCL), Diabetes Camp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 14 May 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.
Detailed description
This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - <18 years) with T1D who currently manage their diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard HCL System - HCL System with Smart Bolus Calculator | Other | Device: Standard HCL System, Device: HCL System with Smart Bolus CalculatorUse of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity |
| HCL System with Smart Bolus Calculator - Standard HCL System | Other | Device: Standard HCL System, Device: HCL System with Smart Bolus CalculatorUse of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Age ≥12 and <18 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year
- Currently using insulin for at least six months
- Currently using an insulin pump for at least three months
- Currently using a CGM system for at least three months
Key exclusion criteria (15 listed)
- Hemoglobin A1c <5% or >10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL
- History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
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 |
|---|---|---|
| Standard HCL SystemStandard HCL system (USS Virginia) | Device | HCL System with Smart Bolus Calculator - Standard HCL System, Standard HCL System - HCL System with Smart Bolus Calculator |
| HCL System with Smart Bolus CalculatorHCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity | Device | HCL System with Smart Bolus Calculator - Standard HCL System, Standard HCL System - HCL System with Smart Bolus Calculator |
Primary outcome
Low Blood Glucose Index (LBGI)
Time frame: 4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)
LBGI computed from CGM collected in the four hours following the dinner meal. LBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation: rL(i) = 10 x (1.509 x (log(CGM(i))^1.084 - 5.381))^2, if CGM(i) <=112.5 mg/dL; rL(i) = 0, if CGM(i) >112.5 mg/dL 2. Averaging the risk scores rL(i), i=1,...,N. The hypoglycemia risk score ranges from 0 for CGM readings >112.5 mg/dL (no hypoglycemia risk) to 100 for CGM readings =20 mg/dL (maximum hypoglycemia risk); consequently, LBGI can theoretically assume values between 0 and 100 as well. Clinically relevant LBGI thresholds have been defined: 1. LBGI <2.5: low hypoglycemia risk 2. LBGI in 2.5-5: moderate hypoglycemia risk 3. LBGI >5: high hypoglycemia risk.
6 secondary outcomes
Percentage of Time Spent Below 70 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent in 70-180 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent Above 180 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
High Blood Glucose Index (HBGI)
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
CGM Coefficient of Variation
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Total Amount of Carbohydrate Administered as Rescue Treatments
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Chiara Fabris, PhD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard HCL System and HCL System with Smart Bolus Calculator 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 19 inclusion and 15 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: finished, as of the sponsor's last update on 30 May 2024. 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?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Blood Glucose Index (LBGI) (time frame: 4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.