Status:
COMPLETED
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Tandem Diabetes Care, Inc.
DexCom, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
Detailed Description
This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a s...
Eligibility Criteria
Inclusion
- Criteria for documented hyperglycemia (at least 1 must be met):
- Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- Criteria for requiring insulin at diagnosis (both criteria must be met):
- Daily insulin therapy for ≥ 6 months
- Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose suspend, predictive suspend, or artificial pancreas functionality on insulin pump during study)
- Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
- 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
- Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.
- 8\. If the participant is less than 13 years of age and the parents or the study team request it, at least one parent commit to stay with the study subject at the camp site 9. A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the AP system at home
Exclusion
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- History of altitude sickness
- Chronic pulmonary conditions that could impair oxygenation
- 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).
- Pregnancy
- Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use while wearing the CGM. The camp 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 (for parent and/or child):
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03369067
Start Date
December 18 2017
End Date
April 15 2018
Last Update
October 1 2024
Active Locations (3)
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1
Stanford University
Stanford, California, United States, 94304
2
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
3
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903