Type 1 Diabetes MellitusNCT03369067

Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

A study testing Dexcom CGM G5 and Continuous Subcutaneous Insulin Infusion in people with Type 1 Diabetes Mellitus, run by University of Virginia at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: Dexcom CGM G5 and Continuous Subcutaneous Insulin Infusion
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 3 sitesUnited States
Study dates: 18 Dec 2017to 15 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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)

Show all 11Show fewer

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued

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.

Read the 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.

Conditions: Type 1 Diabetes Mellitus
Being tested: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6, Dexcom CGM G5, Continuous Subcutaneous Insulin Infusion
Keywords: Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6Device
Also called Artificial Pancreas, Automated Insulin Delivery Device
Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
Dexcom CGM G5Device
Also called Continuous Glucose monitoring
The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change.
The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes
Continuous Subcutaneous Insulin InfusionDevice
Also called Insulin pump
Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.

Study groups in NCT03369067
Study group	Role	What they receive
Artificial Pancreas Therapy	Experimental	Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. Receives: Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6; Device: Dexcom CGM G5
Sensor Augmented Pump Therapy	Placebo comparator	Subjects will use a Dexcom CGM G5 and their Continuous Subcutaneous Insulin Infusion devices (insulin pumps) to modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. Receives: Device: Dexcom CGM G5; Device: Continuous Subcutaneous Insulin Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Time Spent Between 70 and 180 mg/dL
The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.
Measured: Overall [48hr study admission]
Percent Time Spent Between 70 and 180 mg/dL
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm.
Measured: Daytime [7am - 11pm]
Percent Time Spent Between 70 and 180 mg/dL
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am.
Measured: Overnight [11pm - 7am]
Percent Time Spent Between 70 and 180 mg/dL
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]

Secondary outcomes (45)

Percent Time Spent <50 mg/dL
The percentage of time spent below 50 mg/dL during the Overall period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Measured: Overall [48hr study admission]
Percent Time Spent <54 mg/dL
The percentage of time spent below 54 mg/dL during the Overall period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Measured: Overall [48hr study admission]
Percent Time Spent <60 mg/dL
The percentage of time spent below 60 mg/dL during the Overall period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Measured: Overall [48hr study admission]
Percent Time Spent <70 mg/dL
The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Measured: Overall [48hr study admission]
Percent Time Spent >180 mg/dL
The percentage of time spent above 180 mg/dL during the overall period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Measured: Overall [48hr study admission]
Percent Time Spent >250 mg/dL
The percentage of time spent above 250 mg/dL during the Overall period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Measured: Overall [48hr study admission]
Percent Time Spent >300 mg/dL
The percentage of time spent above 300 mg/dL. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Measured: Overall [48hr study admission]
Mean Glucose
Mean glucose is a measure of the average CGM value in mg/dL during the Overall period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Measured: Overall [48hr study admission]
Glucose Variability
Variability of glucose during the Overall period
Measured: Overall [48hr study admission]
Insulin
Amount (U/kg) of insulin administered during the Overall period
Measured: Overall [48hr study admission]
Carbohydrate (CHO) Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period.
Measured: Overall [48hr study admission]
Percent Time Spent <50 mg/dL
The percentage of time spent below 50 mg/dL during the Daytime period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent <54 mg/dL
The percentage of time spent below 54 mg/dL during the Daytime period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent <60 mg/dL
The percentage of time spent below 60 mg/dL during the Daytime period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent <70 mg/dL
The percentage of time spent below 70 mg/dL during the Daytime period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent >180 mg/dL
The percentage of time spent above 180 mg/dL during the Daytime period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent >250 mg/dL
The percentage of time spent above 250 mg/dL during the Daytime period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Measured: Daytime [7am - 11pm]
Percent Time Spent >300 mg/dL
The percentage of time spent above 300 mg/dL during the Daytime period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Measured: Daytime [7am - 11pm]
Mean Glucose
Mean glucose is a measure of the average CGM value in mg/dL during the Daytime period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Measured: Daytime [7am - 11pm]
Glucose Variability
Variability of glucose during the Daytime period
Measured: Daytime [7am - 11pm]
Insulin
Amount (U/kg) of insulin administered during the Daytime period
Measured: Daytime [7am - 11pm]
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period.
Measured: Daytime [7am - 11pm]
Percent Time Spent <50 mg/dL
The percentage of time spent below 50 mg/dL during the Overnight period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent <54 mg/dL
The percentage of time spent below 54 mg/dL during the Overnight period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent <60 mg/dL
The percentage of time spent below 60 mg/dL during the Overnight period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent <70 mg/dL
The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent Between 70 and 150 mg/dL
This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am.
Measured: Overnight [11pm - 7am]
Percent Time Spent >180 mg/dL
The percentage of time spent above 180 mg/dL during the Overnight period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent >250 mg/dL
The percentage of time spent above 250 mg/dL during the Overnight period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Measured: Overnight [11pm - 7am]
Percent Time Spent >300 mg/dL
The percentage of time spent above 300 mg/dL during the Overnight period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Measured: Overnight [11pm - 7am]
Mean Glucose
Mean glucose is a measure of the average CGM value in mg/dL during the Overnight period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Measured: Overnight [11pm - 7am]
Glucose Variability
Variability of glucose during the Overnight period
Measured: Overnight [11pm - 7am]
Insulin
Amount (U/kg) of insulin administered during the Overnight period
Measured: Overnight [11pm - 7am]
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period.
Measured: Overnight [11pm - 7am]
Percent Time Spent <50 mg/dL
The percentage of time spent below 50 mg/dL during the Skiing period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <54 mg/dL
The percentage of time spent below 54 mg/dL during the Skiing period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <60 mg/dL
The percentage of time spent below 60 mg/dL during the Skiing period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <70 mg/dL
The percentage of time spent below 70 mg/dL during the Skiing period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent >180 mg/dL
The percentage of time spent above 180 mg/dL during the Skiing period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent >250 mg/dL
The percentage of time spent above 250 mg/dL during the Skiing period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent >300 mg/dL
The percentage of time spent above 300 mg/dL during the Skiing period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Mean Glucose
Mean glucose is a measure of the average CGM value in mg/dL during the Skiing period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
Glucose Variability
Variability of glucose during the Skiing period
Measured: Skiing [9:30am-noon and 1:30pm-4pm
Insulin
Amount (U/kg) of insulin administered during the Skiing period
Measured: Skiing [9:30am-noon and 1:30pm-4pm]
CHO Treatment
The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period.
Measured: Skiing [9:30am-noon and 1:30pm-4pm]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201715 Apr 2018

First posted11 Dec 2017
Study start18 Dec 2017
Primary completion15 Apr 2018
Study completion15 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03369067
Sponsor's protocol ID: 20335
Status last verified: Sep 2024
First submitted: 15 Nov 2017
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Publications

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.
PubMed 31099946

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued
ClinicalTrials.gov ID: NCT03369067
Acronym / sponsor ID: 20335
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Tandem Diabetes Care, Inc., DexCom, Inc.
Study start: 18 Dec 2017 (actual)
Primary completion: 15 Apr 2018 (actual)
Study completion: 15 Apr 2018 (actual)
First posted: 11 Dec 2017 (actual)
Results: Posted 1 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Artificial Pancreas Therapy	Experimental	Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6, Device: Dexcom CGM G5Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety.
Sensor Augmented Pump Therapy	Placebo comparator	Device: Dexcom CGM G5, Device: Continuous Subcutaneous Insulin InfusionSubjects will use a Dexcom CGM G5 and their Continuous Subcutaneous Insulin Infusion devices (insulin pumps) to modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety.

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Criteria for documented hyperglycemia (at least 1 must be met):
Criteria for requiring insulin at diagnosis (both criteria must be met):
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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6Also: Artificial Pancreas, Automated Insulin Delivery DeviceSubjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].	Device	Artificial Pancreas Therapy
Dexcom CGM G5Also: Continuous Glucose monitoringThe Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change. The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes	Device	Artificial Pancreas Therapy, Sensor Augmented Pump Therapy
Continuous Subcutaneous Insulin InfusionAlso: Insulin pumpSubjects will use a subcutaneous pump to deliver insulin and control their glycemia.	Device	Sensor Augmented Pump Therapy

Primary outcome

Percent Time Spent Between 70 and 180 mg/dL
Time frame: Overall [48hr study admission]
The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.
Percent Time Spent Between 70 and 180 mg/dL
Time frame: Daytime [7am - 11pm]
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm.
Percent Time Spent Between 70 and 180 mg/dL
Time frame: Overnight [11pm - 7am]
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am.
Percent Time Spent Between 70 and 180 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.

45 secondary outcomes

Percent Time Spent <50 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent <54 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent <60 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent <70 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent >180 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent >250 mg/dL
Time frame: Overall [48hr study admission]
Percent Time Spent >300 mg/dL
Time frame: Overall [48hr study admission]
Mean Glucose
Time frame: Overall [48hr study admission]
Glucose Variability
Time frame: Overall [48hr study admission]
Insulin
Time frame: Overall [48hr study admission]
Carbohydrate (CHO) Treatment
Time frame: Overall [48hr study admission]
Percent Time Spent <50 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent <54 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent <60 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent <70 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent >180 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent >250 mg/dL
Time frame: Daytime [7am - 11pm]
Percent Time Spent >300 mg/dL
Time frame: Daytime [7am - 11pm]
Mean Glucose
Time frame: Daytime [7am - 11pm]
Glucose Variability
Time frame: Daytime [7am - 11pm]
Insulin
Time frame: Daytime [7am - 11pm]
CHO Treatment
Time frame: Daytime [7am - 11pm]
Percent Time Spent <50 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent <54 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent <60 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent <70 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent Between 70 and 150 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent >180 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent >250 mg/dL
Time frame: Overnight [11pm - 7am]
Percent Time Spent >300 mg/dL
Time frame: Overnight [11pm - 7am]
Mean Glucose
Time frame: Overnight [11pm - 7am]
Glucose Variability
Time frame: Overnight [11pm - 7am]
Insulin
Time frame: Overnight [11pm - 7am]
CHO Treatment
Time frame: Overnight [11pm - 7am]
Percent Time Spent <50 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <54 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <60 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent <70 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent >180 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]
Percent Time Spent >250 mg/dL
Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

Results and safety

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental AP Group	24	24
Control SAP Group	24	24

Primary outcome: Percent Time Spent Between 70 and 180 mg/dL

Time frame: Overall [48hr study admission]. Mean (Standard Deviation). Unit: percentage of time

Measure	Experimental AP Group n = 21	Control SAP Group n = 24
All	66.4 (16.4)	53.9 (24.8)
School-age [6-12 years old]	59.9 (19.5)	57.7 (23.1)
Teens [13-18 years old]	73.5 (8.4)	50 (26.8)

Experimental AP Group vs Control SAP Group: p = 0.010, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.089, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.024, ANOVA

Population analysed: The "All" row is the combined total of participants in the following rows "School-age" and "Teens." Data for three participants were excluded. For one subject, a software error resulted in prolonged AP system downtime. For a second subject, repeated pump occlusions resulted in prolonged system downtime. For the third subject, the Tandem pump was initialized with a sibling's pump settings resulting in strongly biased results.

Primary outcome: Percent Time Spent Between 70 and 180 mg/dL

Time frame: Daytime [7am - 11pm]. Mean (Standard Deviation). Unit: percentage of time

Measure	Experimental AP Group n = 21	Control SAP Group n = 24
All	62.4 (18.8)	54.8 (24.9)
School-age [6-12 years old]	56.4 (22.7)	59.6 (22.3)
Teens [13-18 years old]	68.9 (11.1)	50 (27.3)

Experimental AP Group vs Control SAP Group: p = 0.095, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.104, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.042, ANOVA

Primary outcome: Percent Time Spent Between 70 and 180 mg/dL

Time frame: Overnight [11pm - 7am]. Mean (Standard Deviation). Unit: percentage of time

Measure	Experimental AP Group n = 21	Control SAP Group n = 24
All	78.6 (20.3)	50.9 (34.2)
School-age [6-12 years old]	70.6 (24)	52 (34.3)
Teens [13-18 years old]	87.3 (10.8)	49.9 (35.6)

Experimental AP Group vs Control SAP Group: p <0.001, ANOVA
Experimental AP Group vs Control SAP Group: p >0.2, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.065, ANOVA

Primary outcome: Percent Time Spent Between 70 and 180 mg/dL

Time frame: Skiing [9:30am-noon and 1:30pm-4pm]. Mean (Standard Deviation). Unit: percentage of time

Measure	Experimental AP Group n = 21	Control SAP Group n = 24
All	57.8 (27.3)	55.9 (31.1)
School-age [6-12 years old]	50 (30.7)	65.2 (24)
Teens [13-18 years old]	66.4 (21.1)	46.6 (35.5)

Experimental AP Group vs Control SAP Group: p >0.2, ANOVA
Experimental AP Group vs Control SAP Group: p >0.2, ANOVA
Experimental AP Group vs Control SAP Group: p = 0.063, ANOVA

45 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control SAP Group	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Experimental AP Group	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Limitations and caveats (from the sponsor): Data for 3 participants were excluded. Subject 1: a software error resulted in prolonged AP system downline. The error was identified in data analysis; Subject 2: repeated pump occlusion resulted in prolonged system downtime; Subject 3: study pump initialized with siblings pump settings resulting in strong biased results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31099946Ekhlaspour 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Breton, PhD principal investigator

University of Virginia Center for Diabetes Technology

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom CGM G5 and Continuous Subcutaneous Insulin Infusion in people with Type 1 Diabetes Mellitus, run by University of Virginia at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Time Spent Between 70 and 180 mg/dL (time frame: Overall [48hr study admission]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03369067, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.