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

NCT04255381 | Completed Results DMC FDA Device

• 1 other identifier: 1609018413
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  60 hours

• 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.

  60 hours

• 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

  60 hours

• Safety: Number of Participants Who Experienced an Adverse Event

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

  60 hours

Secondary Outcomes (7)

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

  60 hours

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

  60 hours

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

  60 hours

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

  60 hours

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

  60 hours

Study Arms (1)

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

EXPERIMENTAL

Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system

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

Interventions

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) DEVICE

Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)

Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yale University: lead
• Harvard University: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 35971681 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Stuart Weinzimer
• Organization: Yale University

stuart.weinzimer@yale.edu

203-785-5831

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SIngle arm cohort study

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 1, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)