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Type 1 DiabetesEarly Phase 1NCT02135068

Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

A Early Phase 1 study testing Medtronic MiniMed Closed Loop (CL) System and Snacking in people with Type 1 Diabetes, run by Yale University at 1 site 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

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor… Read more about this study

Who is it for?
Ages 13 to 44 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Medtronic MiniMed Closed Loop (CL) System and Snacking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Jan 2015to Dec 2016
Phase
Early Phase 1
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 13 to 44 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 13-45 years
  • Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required)
  • Duration of T1D ≥ 1 year
  • HbA1c ≤ 9 %
  • Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months
  • Body weight > 40 kg (to accommodate phlebotomy)
Show all 12Show fewer
  • Able to tolerate a 75-minute exercise period of moderate intensity
  • Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study.
  • Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
  • Normal hematocrit
  • Able to give consent (for children <18 years, permission from parents and subject assent will be required)
  • Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Who cannot join

  • Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
  • Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  • Use of any medications (besides insulin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites.
  • Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
  • History of hypoglycemic seizure within last 3 months
  • Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

Other trials in United States

About this study

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

Read the detailed description

This study will be a randomized cross-over study as subjects will be studied under both study conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol). Differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.

Conditions
Type 1 Diabetes
Being tested
Medtronic MiniMed Closed Loop (CL) System, Snacking
Keywords
type 1 diabetes, closed loop insulin delivery systems, exercise, hypoglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia

What participants receive

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

  • Medtronic MiniMed Closed Loop (CL) SystemDevice

    The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.

  • SnackingOther

    Also called Oral glucose

    Up to 45 g of oral glucose via Gatorade

Study groups in NCT02135068
Study groupRoleWhat they receive
CL and exercise with proactive snackingExperimentalSubject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
Receives: Device: Medtronic MiniMed Closed Loop (CL) System; Other: Snacking
CL and exercise without proactive snackingActive comparatorSubject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System
Receives: Device: Medtronic MiniMed Closed Loop (CL) System

What is being measured

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

  1. Nadir blood glucose levels during exercise

    Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.

    Measured: 75 minutes

Secondary outcomes (13)

  1. Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise

    Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions

    Measured: 75 minutes

  2. Mean reduction in blood glucose during exercise

    Mean Reduction in blood glucose from baseline blood glucose during exercise

    Measured: 75 minutes

  3. Mean time blood glucose in target during exercise

    Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions

    Measured: 75 minutes

  4. Mean time blood glucose levels are in target during the overnight period

    Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise.

    Measured: 17 hours

  5. Mean glucose values

    Comparison of the mean daytime and nighttime glucose values

    Measured: 12 hours

  6. Mean 24- hour glucose levels

    Comparison of the mean 24- hour glucose levels

    Measured: 24 hours

  7. insulin delivery during CL therapy

    Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.

    Measured: 24 hours

  8. Incremental meal-related glucose Area Under the Curve

    Assessment of incremental meal related glucose area under the curve will be conducted.

    Measured: 24 hours

  9. Nadir glucose levels following the meals

    Nadir glucose levels following meals will be compared between the two study conditions

    Measured: 24 hours

  10. Area under the curve meal-related plasma insulin level excursion following meals

    Area under the curve meal-related insulin excursion following meals.

    Measured: 24 hours

  11. Nadir glucose levels overnight

    Difference between nadir glucose levels between the two study conditions will be assessed.

    Measured: 12 hours

  12. Mean absolute relative difference (MARD) for each sensor

    Calculation and comparison of the mean absolute relative difference for each sensor will be performed and comparisons between accuracy of the sensors will be done.

    Measured: 24 hours

  13. Mean daytime and nighttime glucose values

    Comparison of the mean daytime and nighttime glucose levels

    Measured: 24 hours

Timeline

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

  1. First posted9 May 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2016
  4. Study completionDec 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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135068
Sponsor's protocol ID
1403013588
Other IDs
T32DK063703
Status last verified
Apr 2020
First submitted
16 Apr 2014
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Medtronic MiniMed Closed Loop (CL) System and Snacking in people with Type 1 Diabetes, run by Yale University at 1 site 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 12 inclusion and 6 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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Nadir blood glucose levels during exercise (time frame: 75 minutes). 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 NCT02135068.

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 20 Apr 2020.

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Clinical Trial NCT02135068 | AzTrials