Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas (AP), Sensor-Augmented Pump (SAP) Therapy, Closed Loop Control, Insulin Pump, Continuous Glucose Monitor (CGM)
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, a subject must meet the following:
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)
Exclusion Criteria: The presence of any of the following is an exclusion for the study:
- 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:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse
Sites / Locations
- University of Colorado, Denver, Barbara Davis Center
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Closed-Loop Control (CLC) System
Sensor Augmented Pump Therapy Group
Subjects 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.
Subjects will manage their own glucose levels during the trial.