Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

Study Overview
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Brief Summary
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The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Detailed Description
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Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.

Official Title
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Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Diabetes Assistant (DiAs) with Closed-Loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type 1 diabetes, The diagnosis of type 1 diabetes is based on the investigator's judgment C peptide levels and antibody determinations are not required Daily insulin therapy for ≥ 12 months Insulin pump therapy for ≥ 3 months Age ≥5 - ≤8 years old Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study Exclusion Criteria: The presence of any of the following is an exclusion for the study: Diabetic ketoacidosis in the past month Hypoglycemic seizure or loss of consciousness in the past 3 months History of seizure disorder (except for hypoglycemic seizure) History of any heart disease including coronary artery disease, heart failure, or arrhythmias Cystic fibrosis Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study. History of ongoing renal disease (other than microalbuminuria). Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine). Subjects requiring other anti-diabetic medications other than insulin (oral or injectable). Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met. Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: Inpatient psychiatric treatment in the past 6 months Uncontrolled adrenal insufficiency

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission. | Device: Diabetes Assistant (DiAs) with Closed-Loop<br>* All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.<br>|
| Experimental: Group B<br>Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission. | Device: Diabetes Assistant (DiAs) with Closed-Loop<br>* All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Sensor Glucose Readings Between 70-180 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 68 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Time Sensor Glucose Readings Are <70 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 68 hours | 
| Percent of Time Sensor Glucose Readings Are >150 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Percent of Time Sensor Glucose Readings Are >180 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 68 hours | 
| Percent of Time Sensor Glucose Readings Are >250 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 68 hours | 
| Percent of Time Sensor Glucose Readings Are >400 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation) | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Distribution of Sensor and Meter Glucose Values (Maximum) | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Distribution of Sensor and Meter Glucose Values (Minimum) | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range) | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Mean BG (as Measured by CGM) | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. | 68 hours | 
| Hypoglycemia Area Under the Curve <60 | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Hypoglycemia Area Under the Curve <70 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Hyperglycemia Area Under the Curve >180 | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Hyperglycemia Area Under the Curve >250 mg/dL | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. | 72 hours | 
| Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL | All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period. | 68 hours | 
| End of Night Blood Glucose | All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor, Pediatric, Insulin Pump