ClinicalTrials.gg
CompletedNCT03394352Updated May 23, 2018

Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

An interventional study of Activity on Board and Usual Diabetes Care in Type 1 Diabetes Mellitus, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-23.

Sponsored by University of Virginia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 73 studies in Diabetes Mellitus, Type 1 by University of Virginia — 4 open to participants now, 4 under way, none of them phase 3. Diabetes Mellitus, Type 1 · University of Virginia.

Enrollment
43rd of 64
15 · median 28
Started
2018
with 5 others
No phase
58 of 73
2 open now
Registered
45th of 73
by date

Among the 73 studies in Diabetes Mellitus, Type 1 by University of Virginia, this one is the 43rd largest by enrollment of the 64 interventional ones that give a count, is one of 6 that started in 2018, is one of 58 with no phase, and was the 45th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

4 of the 73 studies in Diabetes Mellitus, Type 1 by University of Virginia are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 73 studies in Diabetes Mellitus, Type 1 by University of Virginia, or all of them as a file.
02

Study summary

The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.

Read the detailed description

Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.

03

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Type 1 Diabetes Mellitus
  • Insulin pump
  • Continuous Glucose Monitor (CGM)
  • Exercise
  • Activity on Board
  • Decision Support System
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Type 1 Diabetes for at least one year
  2. Using an insulin pump for at least 6 months
  3. Age 18-65
  4. Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections
  5. Access to internet and willing to upload data during the study
  6. Willingness to maintain consistent activity regimen for 28 day collection period
  7. Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all women of child bearing potential. Subjects who become pregnant will be discontinued from the study.
  8. Demonstration of proper mental status and cognition for the study.
  9. An understanding of and willingness to follow the protocol and sign the .

Exclusion criteria

Exclusion Criteria:

  1. Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
  2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
  3. Pregnancy and intent to become pregnant during trial.
  4. Use of acetaminophen is not allowed when CGM is in use
  5. Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide [GLP]-1 agonists, metformin)
  6. Currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise)
  7. Inability to be physically active for more than 30 minutes per day.
  8. Current enrollment in another intervention clinical trial.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Activity on Board

    Blinded CGM data will be collected prior to the Experimental Admission to determine the insulin bolus that will be determined by the activity on board calculator. Subjects will wear a continuous glucose monitor during the study admission.

    Other: Activity on Board

  • Placebo comparator
    Usual Diabetes Care

    Subjects will use their usual diabetes care, including basal rate, correction factor and carbohydrate-insulin ratio. Subjects will determine their own insulin usage during the Control Admission. Subjects will wear a continuous glucose monitor during the study admission.

    Other: Usual Diabetes Care

Interventions

  • OtherActivity on Board

    During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission.

  • OtherUsual Diabetes Care

    Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission.

06

What researchers measure

Primary outcomes

  1. Continuous Glucose Monitor metrics

    Record CGM metrics with the primary outcome analysis of percentage time \<70 mg/dL by CGM following exercise comparing the experimental to control admission

    Time frame: about 9-12 hours

07

Study locations

1 site
  • University of Virginia Center for Diabetes Technology
    Charlottesville, Virginia 22903, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in May 2018, 3 months.

Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 3 months is below that.

Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2018
First posted
Jan 9, 2018
StartActual
Jan 17, 2018
Primary completionActual
May 11, 2018
CompletionActual
May 11, 2018
Last update
May 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03394352
Responsible party
Marc Breton (Principal Investigator, University of Virginia) — Principal investigator
First posted
Jan 9, 2018
Start date
Jan 17, 2018
Primary completion
May 11, 2018
Completion
May 11, 2018
Last update
May 23, 2018

Study contacts

Marc D. Breton, Ph.D.
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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