Diabetes Mellitus, Type 1
Conditions
Keywords
Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor, Pediatric, Insulin Pump
Brief summary
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
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.
Interventions
DEVICEDiabetes Assistant (DiAs) with Closed-Loop
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.
Sponsors
DexCom, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Sensor Glucose Readings Between 70-180 mg/dL | 68 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time Sensor Glucose Readings Are >150 mg/dL | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Percent of Time Sensor Glucose Readings Are >180 mg/dL | 68 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Percent of Time Sensor Glucose Readings Are >250 mg/dL | 68 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Percent of Time Sensor Glucose Readings Are >400 mg/dL | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation) | 72 hours | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. |
| Distribution of Sensor and Meter Glucose Values (Maximum) | 72 hours | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. |
| Distribution of Sensor and Meter Glucose Values (Minimum) | 72 hours | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. |
| Percent of Time Sensor Glucose Readings Are <70 mg/dL | 68 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Mean BG (as Measured by CGM) | 68 hours | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. |
| Hypoglycemia Area Under the Curve <60 | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Hypoglycemia Area Under the Curve <70 mg/dL | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Hyperglycemia Area Under the Curve >180 | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Hyperglycemia Area Under the Curve >250 mg/dL | 72 hours | All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period. |
| Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL | 68 hours | All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period. |
| End of Night Blood Glucose | 72 hours | 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. |
| Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range) | 72 hours | All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A- Home Care Before Closed-Loop Control 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.
Diabetes Assistant (DiAs) with Closed-Loop: 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. | 6 |
| Group B- Closed-Loop Control Before Home Care 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.
Diabetes Assistant (DiAs) with Closed-Loop: 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Group B- Closed-Loop Control Before Home Care | Group A- Home Care Before Closed-Loop Control |
|---|---|---|---|
| Age, Continuous | 7 years | 7 years | 7 years |
| Diabetes Duration | 3.7 years | 3.3 years | 4.9 years |
| HbA1c | 7.7 percentage of HbA1C | 7.6 percentage of HbA1C | 7.7 percentage of HbA1C |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Percent of Sensor Glucose Readings Between 70-180 mg/dL | 46.9 percentage of time in range | Standard Deviation 2.7 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Percent of Sensor Glucose Readings Between 70-180 mg/dL | 73.1 percentage of time in range | Standard Deviation 2.7 |
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL | 4.0 events per subject, glucometer <70mg/dL | Standard Deviation 1 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL | 3.3 events per subject, glucometer <70mg/dL | Standard Deviation 1 |
Secondary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Mean BG (as Measured by CGM) | 190 mg/dL | Standard Deviation 7.4 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Mean BG (as Measured by CGM) | 152 mg/dL | Standard Deviation 4.2 |
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Percent of Time Sensor Glucose Readings Are >180 mg/dL | 51.5 percentage of time above 180 mg/dL | Standard Deviation 0.8 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Percent of Time Sensor Glucose Readings Are >180 mg/dL | 25.8 percentage of time above 180 mg/dL | Standard Deviation 2.8 |
Secondary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Percent of Time Sensor Glucose Readings Are >250 mg/dL | 20.8 percentage of time above 250 mg/dL | Standard Deviation 9.9 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Percent of Time Sensor Glucose Readings Are >250 mg/dL | 6.3 percentage of time above 250 mg/dL | Standard Deviation 5.4 |
Secondary
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.
Time frame: 72 hours
Secondary
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.
Time frame: 68 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Care (Pump+CGM) | Percent of Time Sensor Glucose Readings Are <70 mg/dL | 1.6 percentage of time below 70 mg/dL | Standard Deviation 1.2 |
| Diabetes Assistant (DiAs) With Closed-Loop Control | Percent of Time Sensor Glucose Readings Are <70 mg/dL | 1.1 percentage of time below 70 mg/dL | Standard Deviation 1.1 |