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

Primary Purpose

Type1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

About this trial

This is an interventional treatment trial for Type1 Diabetes focused on measuring type 1 diabetes, artificial pancreas, closed-loop, automated insulin delivery

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Arm Description

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

Outcomes

Primary Outcome Measures

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

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.

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

Safety: Number of Participants Who Experienced an Adverse Event

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

Secondary Outcome Measures

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

Mean meter and sensor glucose levels (mg/dL)

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

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

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

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

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

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

Full Information

NCT ID

NCT04255381

First Posted

January 29, 2020

Last Updated

May 11, 2022

Sponsor

Yale University

Collaborators

Harvard University

1. Study Identification

Unique Protocol Identification Number

NCT04255381

Brief Title

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

Acronym

HY-GRAID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes

Keywords

type 1 diabetes, artificial pancreas, closed-loop, automated insulin delivery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

SIngle arm cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Intervention Description

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

60 hours

Title

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))

Description

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

Title

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

Description

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

Title

Safety: Number of Participants Who Experienced an Adverse Event

Description

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

Time Frame

60 hours

Secondary Outcome Measure Information:

Title

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

Description

Mean meter and sensor glucose levels (mg/dL)

Time Frame

60 hours

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

Percent Time AP System Active

Description

Time Frame

60 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35971681

Citation

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. 2022 Aug 16:19322968221116384. doi: 10.1177/19322968221116384. Online ahead of print.

Results Reference

derived

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

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