Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 25
Updated:9/21/2018
Start Date:January 2016
End Date:April 2016

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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.

The object of this study is to evaluate the Closed-Loop Control (CLC) in an environment where
muscle glycogen is systematically depleted, glucose uptake systematically increased, and meal
sizes are naturally larger than normal: a week of camp at high altitude, with the concomitant
variable of oxygen consumption that this environment involves; during the winter, that will
expose and challenge the different components of the system during cold temperatures, and
with twice daily practice of physical activity designed to deplete glycogen reserves such as
skiing.

This proposal aims to demonstrate the superiority of the CLC, also known as Artificial
Pancreas (AP), compared to the state-of-the art system available on the market:
Sensor-augmented pump (SAP). This system has shown to diminish hypoglycemic events by setting
the alarms on the continues glucose monitor (CGM) and taken action, such as performing
self-monitoring blood glucose (SMBG) and treating if it is confirm to be low.

Inclusion Criteria: To be eligible for the study, a subject must meet the following:

1. 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

2. Criteria for requiring insulin at diagnosis (both criteria must be met):

- Daily insulin therapy for ≥ 12 months

- Insulin pump therapy for ≥ 3 months

3. Age 10 - 25 years

4. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the
continuous glucose monitor.

5. Willingness to wear a continuous glucose sensor and physiological monitor for the
duration of the study

6. 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:

1. Diabetic ketoacidosis in the past 6 months

2. Hypoglycemic seizure or loss of consciousness in the past 6 months

3. History of seizure disorder (except for hypoglycemic seizure)

4. History of any heart disease including coronary artery disease, heart failure, or
arrhythmias

5. History of altitude sickness

6. Chronic pulmonary conditions that could impair oxygenation

7. Cystic fibrosis

8. 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.

9. History of ongoing renal disease (other than microalbuminuria).

10. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or
Glargine).

11. Subjects requiring other anti-diabetic medications other than insulin (oral or
injectable).

12. Pregnancy

13. Sexually active females who do not practice acceptable contraceptive methods to
prevent pregnancy.

14. 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.

15. 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
We found this trial at
2
sites
Charlottesville, Virginia 22903
(434) 924-0311
Phone: 434-243-1395
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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