N/A
Completed N=20
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
Type1 Diabetes
Source: ClinicalTrials.gov NCT04255381 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL)) — 19; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL)) |
19; 1 | — |
| PRIMARY 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)) |
19; 1 | — |
| PRIMARY 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 |
0; 0; 20 | — |
| PRIMARY Safety: Number of Participants Who Experienced an Adverse Event |
0; 0; 0; 0; 20 | — |
| SECONDARY Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL) |
161.4; 172 | — |
| SECONDARY Percent Sensor Glucose Time in Range (70-180 mg/dL) |
63.5 | — |
| SECONDARY Percent Sensor Glucose Time Below Range (<70 mg/dL) |
1.8 | — |
| SECONDARY Percent Sensor Glucose Time Above Range (>180 mg/dL) |
37.4 | — |
| SECONDARY Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL) |
0.6 | — |
| SECONDARY Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL) |
12.1 | — |
| SECONDARY Percent Time AP System Active |
92.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT04255381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.