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Type 1 Diabetes MellitusNCT02604524

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

A study testing Sensor Augmented Pump Therapy in people with Type 1 Diabetes Mellitus, run by Daniel Chernavvsky, MD, CRC at 2 sites in United States.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 25 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Sensor Augmented Pump Therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
2 sitesUnited States
Study dates
Jan 2016to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

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 10 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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
  1. Criteria for requiring insulin at diagnosis (both criteria must be met):
  • Daily insulin therapy for ≥ 12 months
  • Insulin pump therapy for ≥ 3 months
  1. Age 10 - 25 years
  2. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  3. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
  4. 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado, Denver, Barbara Davis Center

    Aurora, Colorado, 80045

  • University of Virginia

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Closed-Loop Control, Sensor Augmented Pump Therapy
Keywords
Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas (AP), Sensor-Augmented Pump (SAP) Therapy, Closed Loop Control, Insulin Pump, Continuous Glucose Monitor (CGM)
Medical subject headings
Diabetes Mellitus, Type 1, Lymphoproliferative Disorders

What participants receive

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

  • Closed-Loop ControlDevice

    Also called CLC

    Subjects will use the CLC during 5 nights/6 days at a ski camp.

  • Sensor Augmented Pump TherapyOther

    Also called SAP

    Subjects using their personal pumps with study CGM.

Study groups in NCT02604524
Study groupRoleWhat they receive
Closed-Loop Control (CLC) SystemExperimentalSubjects 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.
Receives: Device: Closed-Loop Control
Sensor Augmented Pump Therapy GroupPlacebo comparatorSubjects will manage their own glucose levels during the trial.
Receives: Other: Sensor Augmented Pump Therapy

What is being measured

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

  1. Time in range when using closed-loop compared with SAP.

    Measured: 120-144 hours

Secondary outcomes (1)

  1. Reduction of hypoglycemia episodes when using closed-loop

    assessed by the number of hypoglycemia treatments were needed for each group

    Measured: 120-144 hours

Timeline

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

  1. First posted13 Nov 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604524
Sponsor's protocol ID
18529
Other IDs
DP3DK106826-01
Status last verified
Nov 2017
First submitted
6 Nov 2015
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: undetermined

Publications

  • 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.

    PubMed 28855239

Questions about this trial

What is this clinical trial studying?

A study testing Sensor Augmented Pump Therapy in people with Type 1 Diabetes Mellitus, run by Daniel Chernavvsky, MD, CRC at 2 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?

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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time in range when using closed-loop compared with SAP. (time frame: 120-144 hours). 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 NCT02604524, 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 19 Sep 2018; AzTrials last refreshed its copy on 28 Oct 2026.

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