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CompletedNCT04255381HY-GRAIDUpdated Jun 1, 2022Results posted

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

An interventional study of Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) in Type1 Diabetes, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2018, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
2 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type1 Diabetes

Keywords

  • type 1 diabetes
  • artificial pancreas
  • closed-loop
  • automated insulin delivery
03

In context

Diabetes Mellitus, Type 1

3,521 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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
  2. 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
  3. A1c level ≤ 10.0%
  4. Use of insulin pump and carbohydrate counting for ≥ 3 months
  5. Average total daily insulin dose of at least 10 units/day
  6. Current or past use of Continuous Glucose Monitoring (CGM) is desirable but NOT required
  7. Normal renal function as measured within 6 months of enrollment
  8. Normal thyroid function within 6 months of enrollment, or if previously diagnosed with hypothyroidism, documented within 3 months of enrollment
  9. Parent/guardian agrees to stay at hotel with subject for duration of hotel phase and has cell phone that can send/receive text messages
  10. Subject and participating parent/guardian speak and comprehend English

Exclusion criteria

Exclusion Criteria:

  1. Episode of diabetic ketoacidosis (DKA) within 6 months of enrollment
  2. Episode of severe hypoglycemia (seizure, loss of consciousness) within 6 months of enrollment
  3. Use of medications (other than insulin) known to affect BG levels within 4 weeks of enrollment - examples include systemic glucocorticoids, metformin, pramlintide, liraglutide)
  4. Current use of other medications, that in opinion of investigator, would interfere with safety or effectiveness of the study including acetaminophen
  5. Medical disorder, that in opinion of investigator, would be contraindication for inclusion; hypothyroidism and celiac disease are NOT exclusion if under good control
  6. Female subjects of childbearing potential unwilling to have pregnancy testing
  7. Female subject currently pregnant or lactating
  8. History of alcohol or drug abuse, documented eating disorder, or inpatient psychiatric treatment within 6 months of enrollment
  9. Subject is currently participating in another research study involving an investigational drug or device
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

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

    Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system

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

Interventions

  • DeviceZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

    Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: 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

    Time frame: 60 hours

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

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

    Time frame: 60 hours

Secondary outcomes

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

    Mean meter and sensor glucose levels (mg/dL)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 60 hours

07

Results

Posted Jan 24, 2022

Participant flow

Participant flow — Overall Study
MilestoneZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Started20
Completed20
Not completed0

Outcome measures

PrimaryHypoglycemia 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

Time frame:
60 hours
Reported as:
Count of participants · Participants
Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
ParticipantsZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
No more than one confirmed BG < 50 mg/dL19
More than one confirmed BG < 50 mg/dL1
PrimaryHyperglycemia 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.

Time frame:
60 hours
Reported as:
Count of participants · Participants
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))
ParticipantsZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
No more than 2 confirmed BG≥300 mg/dL > 2 hours and no BG≥400 mg/dL not due to infusion site failure19
More than 2 two confirmed BG ≥ 300 mg/dL >2 hours or BG ≥ 400 mg/dL not due to infusion site failure1
PrimaryBlood 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

Time frame:
60 hours
Reported as:
Count of participants · Participants
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
ParticipantsZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
blood ketone levels > 1.0 mmol/l for longer than 2 hours0
blood ketone levels > 3.0 mmol/l0
blood ketone levels < 1.0 mmol/l for longer than 2 hours or blood ketone levels < 3.0 mmol/l20
PrimarySafety: Number of Participants Who Experienced an Adverse Event

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

Time frame:
60 hours
Reported as:
Count of participants · Participants
Safety: Number of Participants Who Experienced an Adverse Event
ParticipantsZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
seizures0
loss of consciousness0
severe hypoglycemia0
diabetic ketoacidosis0
no adverse event20
SecondaryMean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)

Mean meter and sensor glucose levels (mg/dL)

Time frame:
60 hours
Reported as:
Mean · mg/dL
Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)
mg/dLZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Meter blood glucose161.4 ± 39.8
Sensor glucose172 ± 26
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Sensor Glucose Time in Range (70-180 mg/dL)
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Sensor Glucose Time in Range (70-180 mg/dL)63.5 ± 14.4
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Sensor Glucose Time Below Range (<70 mg/dL)
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Sensor Glucose Time Below Range (<70 mg/dL)1.8 ± 1.4
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Sensor Glucose Time Above Range (>180 mg/dL)
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Sensor Glucose Time Above Range (>180 mg/dL)37.4 ± 14.8
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)0.6 ± 0.7
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)12.1 ± 10.3
SecondaryPercent 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

Time frame:
60 hours
Reported as:
Mean · percentage of time
Percent Time AP System Active
percentage of timeZone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Percent Time AP System Active92.7 ± 7.0

Adverse events

Collected over 60 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Mean11.3 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Female8
Male12
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Hispanic or Latino5
Not Hispanic or Latino15
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White17
More than one race2
Unknown or Not Reported0
Duration of Type I Diabetes
Duration of Type I Diabetes(years)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Mean5.0 ± 3.2
Baseline A1c
Baseline A1c(percentage of HbA1c)Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Mean7.6 ± 0.9
08

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06511, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 29, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04255381
Lead sponsor
Yale University
Collaborators
Harvard University
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Oct 1, 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Results posted
Jan 24, 2022
Last update
Jun 1, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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