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Type1 DiabetesHY-GRAIDNCT04255381

Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)

A study of Type1 Diabetes, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to… Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Type1 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 31 Dec 2020
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 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 2- <18 years; for first cohort(s), subjects will be 12-17 years; additional age brackets will be 8-11 years and then <8 years
  • Type 1 diabetes for ≥ 1 year duration - the diagnosis of type 1 diabetes will be based on the history of ketosis/ketoacidosis at diagnosis or laboratory evidence of islet-cell auto-immunity
  • A1c level ≤ 10.0%
  • Use of insulin pump and carbohydrate counting for ≥ 3 months
  • Average total daily insulin dose of at least 10 units/day
  • Current or past use of Continuous Glucose Monitoring (CGM) is desirable but NOT required
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  • Normal renal function as measured within 6 months of enrollment
  • Normal thyroid function within 6 months of enrollment, or if previously diagnosed with hypothyroidism, documented within 3 months of enrollment
  • Parent/guardian agrees to stay at hotel with subject for duration of hotel phase and has cell phone that can send/receive text messages
  • Subject and participating parent/guardian speak and comprehend English

Who cannot join

  • Episode of diabetic ketoacidosis (DKA) within 6 months of enrollment
  • Episode of severe hypoglycemia (seizure, loss of consciousness) within 6 months of enrollment
  • Use of medications (other than insulin) known to affect BG levels within 4 weeks of enrollment - examples include systemic glucocorticoids, metformin, pramlintide, liraglutide)
  • Current use of other medications, that in opinion of investigator, would interfere with safety or effectiveness of the study including acetaminophen
  • Medical disorder, that in opinion of investigator, would be contraindication for inclusion; hypothyroidism and celiac disease are NOT exclusion if under good control
  • Female subjects of childbearing potential unwilling to have pregnancy testing
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  • Female subject currently pregnant or lactating
  • History of alcohol or drug abuse, documented eating disorder, or inpatient psychiatric treatment within 6 months of enrollment
  • Subject is currently participating in another research study involving an investigational drug or device

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University

    New Haven, Connecticut, 06511

Other trials in United States

About this study

The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.

Read the detailed description

The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise.

The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents.

Conditions
Type1 Diabetes
Being tested
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Keywords
type 1 diabetes, artificial pancreas, closed-loop, automated insulin delivery
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)Device

    Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Study groups in NCT04255381
Study groupRoleWhat they receive
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)ExperimentalUse Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system
Receives: Device: Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))

    Number of participants with more than one confirmed BG < 50 mg/dL

    Measured: 60 hours

  2. Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL))

    No more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no BG ≥ 400 mg/dL, unless determined to be from an infusion site failure.

    Measured: 60 hours

  3. Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l

    Number of participants with blood ketone level > 1.0 mmol/l for longer than 2 hours, and no blood ketone level >3.0 mmol/L, unless determined to be from an infusion site. failure

    Measured: 60 hours

  4. Safety: Number of Participants Who Experienced an Adverse Event

    Adverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis

    Measured: 60 hours

Secondary outcomes (7)

  1. Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)

    Mean meter and sensor glucose levels (mg/dL)

    Measured: 60 hours

  2. Percent Sensor Glucose Time in Range (70-180 mg/dL)

    Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is between 70-180 mg/dL

    Measured: 60 hours

  3. Percent Sensor Glucose Time Below Range (<70 mg/dL)

    Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 70 mg/dL

    Measured: 60 hours

  4. Percent Sensor Glucose Time Above Range (>180 mg/dL)

    Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 180 mg/dL

    Measured: 60 hours

  5. Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)

    Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 60 mg/dL

    Measured: 60 hours

  6. Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)

    Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 250 mg/dL

    Measured: 60 hours

  7. Percent Time AP System Active

    Percentage of time, over the whole evaluation period, during which the sensor and pump are determined to be wirelessly connected and communicating with each other, based on duration of alert and error messages indicated by the system

    Measured: 60 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Not applicable
Intervention model
Single group
Model description
SIngle arm cohort study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255381
Sponsor's protocol ID
1609018413
Acronym
HY-GRAID
Status last verified
May 2022
First submitted
29 Jan 2020
Last updated
1 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Deshpande S, Weinzimer SA, Gibbons K, Nally LM, Weyman K, Carria L, Zgorski M, Laffel LM, Doyle FJ 3rd, Dassau E. Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. J Diabetes Sci Technol. 2024 Mar;18(2):363-371. doi: 10.1177/19322968221116384. Epub 2022 Aug 16.

    PubMed 35971681

Questions about this trial

What is this clinical trial studying?

A study of Type1 Diabetes, run by Yale University 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 10 inclusion and 9 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 1 Jun 2022. 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 24 Jan 2022). 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?

Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL)) (time frame: 60 hours). The study lists 4 primary outcomes in all. 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 NCT04255381, which also lists 1 linked publication.

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 1 Jun 2022.

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