Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor, Pediatric, Insulin Pump
Eligibility Criteria
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
Sites / Locations
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A
Group B
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.
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.