Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp
2 other identifiers
interventional
32
1 country
2
Brief Summary
The biggest challenges for glycemic control during the day time involve meals and exercise variations, which are impacted by age, fitness level, duration, intensity and history of exercise. Meal variability has the benefit that meals are typically announced and quantified. Glucose control around exercise, on the other hand, is more complicated if the patient doesn't announce a change in activity level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 19, 2018
November 1, 2017
3 months
November 6, 2015
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in range when using closed-loop compared with SAP.
120-144 hours
Secondary Outcomes (1)
Reduction of hypoglycemia episodes when using closed-loop
120-144 hours
Study Arms (2)
Closed-Loop Control (CLC) System
EXPERIMENTALSubjects will use the Closed-Loop Control system in an attempt to maintain blood glucose in a certain range during the day and at night during the trial.
Sensor Augmented Pump Therapy Group
PLACEBO COMPARATORSubjects will manage their own glucose levels during the trial.
Interventions
Subjects will use the CLC during 5 nights/6 days at a ski camp.
Subjects using their personal pumps with study CGM.
Eligibility Criteria
You may qualify if:
- 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 ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age 10 - 25 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
- Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD)
You may not qualify if:
- 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
- Sexually active females who do not practice acceptable contraceptive methods to prevent 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:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniel Chernavvsky, MD, CRClead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- DexCom, Inc.collaborator
Study Sites (2)
University of Colorado, Denver, Barbara Davis Center
Aurora, Colorado, 80045, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Breton MD, Chernavvsky DR, Forlenza GP, DeBoer MD, Robic J, Wadwa RP, Messer LH, Kovatchev BP, Maahs DM. Closed-Loop Control During Intense Prolonged Outdoor Exercise in Adolescents With Type 1 Diabetes: The Artificial Pancreas Ski Study. Diabetes Care. 2017 Dec;40(12):1644-1650. doi: 10.2337/dc17-0883. Epub 2017 Aug 30.
PMID: 28855239RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel R. Chernavvsky, MD, CRC
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 13, 2015
Study Start
January 1, 2016
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 19, 2018
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will share
undetermined