N/A
Completed N=12
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02750267 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Percent of Sensor Glucose Readings Between 70-180 mg/dL — 46.9; 73.1 percentage of time in range
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Sensor Glucose Readings Between 70-180 mg/dL |
46.9; 73.1 | — |
| SECONDARY Percent of Time Sensor Glucose Readings Are <70 mg/dL |
1.6; 1.1 | — |
| SECONDARY Percent of Time Sensor Glucose Readings Are >150 mg/dL |
— | — |
| SECONDARY Percent of Time Sensor Glucose Readings Are >180 mg/dL |
51.5; 25.8 | — |
| SECONDARY Percent of Time Sensor Glucose Readings Are >250 mg/dL |
20.8; 6.3 | — |
| SECONDARY Percent of Time Sensor Glucose Readings Are >400 mg/dL |
— | — |
| SECONDARY Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation) |
— | — |
| SECONDARY Distribution of Sensor and Meter Glucose Values (Maximum) |
— | — |
| SECONDARY Distribution of Sensor and Meter Glucose Values (Minimum) |
— | — |
| SECONDARY Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range) |
— | — |
| SECONDARY Mean BG (as Measured by CGM) |
190; 152 | — |
| SECONDARY Hypoglycemia Area Under the Curve <60 |
— | — |
| SECONDARY Hypoglycemia Area Under the Curve <70 mg/dL |
— | — |
| SECONDARY Hyperglycemia Area Under the Curve >180 |
— | — |
| SECONDARY Hyperglycemia Area Under the Curve >250 mg/dL |
— | — |
| SECONDARY Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL |
4.0; 3.3 | — |
| SECONDARY End of Night Blood Glucose |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02750267). 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.