Clinical trial NCT03369067: Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
Official title: Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas (AP)
Continuous Glucose Monitor (CGM)
Closed Loop Control (CLC)
Insulin Pump
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Tandem Diabetes Care, Inc.
name: DexCom, Inc.
First posted: 2017-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a \~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a \~78 hour home use.

Eligibility criteria: Inclusion Criteria:

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 ≥ 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)
3. Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 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. 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 Criteria:

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. 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.
14. 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

Primary outcomes:
measure: Percent Time Spent Between 70 and 180 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent Between 70 and 180 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent Between 70 and 180 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent Between 70 and 180 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
Secondary outcomes:
measure: Percent Time Spent <50 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent <54 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent <60 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent <70 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent >180 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent >250 mg/dL
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent >300 mg/dL
timeFrame: Overall [48hr study admission]
measure: Mean Glucose
timeFrame: Overall [48hr study admission]
measure: Glucose Variability
timeFrame: Overall [48hr study admission]
measure: Insulin
timeFrame: Overall [48hr study admission]
measure: Carbohydrate (CHO) Treatment
timeFrame: Overall [48hr study admission]
measure: Percent Time Spent <50 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent <54 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent <60 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent <70 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent >180 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent >250 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent >300 mg/dL
timeFrame: Daytime [7am - 11pm]
measure: Mean Glucose
timeFrame: Daytime [7am - 11pm]
measure: Glucose Variability
timeFrame: Daytime [7am - 11pm]
measure: Insulin
timeFrame: Daytime [7am - 11pm]
measure: CHO Treatment
timeFrame: Daytime [7am - 11pm]
measure: Percent Time Spent <50 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent <54 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent <60 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent <70 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent Between 70 and 150 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent >180 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent >250 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent >300 mg/dL
timeFrame: Overnight [11pm - 7am]
measure: Mean Glucose
timeFrame: Overnight [11pm - 7am]
measure: Glucose Variability
timeFrame: Overnight [11pm - 7am]
measure: Insulin
timeFrame: Overnight [11pm - 7am]
measure: CHO Treatment
timeFrame: Overnight [11pm - 7am]
measure: Percent Time Spent <50 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent <54 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent <60 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent <70 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent >180 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent >250 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Percent Time Spent >300 mg/dL
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Mean Glucose
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: Glucose Variability
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm
measure: Insulin
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
measure: CHO Treatment
timeFrame: Skiing [9:30am-noon and 1:30pm-4pm]
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center, University of Colorado
state: Colorado
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia Center for Diabetes Technology
name: Marc Breton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ekhlaspour L, Forlenza GP, Chernavvsky D, Maahs DM, Wadwa RP, Deboer MD, Messer LH, Town M, Pinnata J, Kruse G, Kovatchev BP, Buckingham BA, Breton MD. Closed loop control in adolescents and children during winter sports: Use of the Tandem Control-IQ AP system. Pediatr Diabetes. 2019 Sep;20(6):759-768. doi: 10.1111/pedi.12867. Epub 2019 May 23.