ClinicalTrials.gg
CompletedNCT03307850Updated Sep 5, 2018

Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes

An interventional study of Observation During Exercise and Stress in Type 1 Diabetes Mellitus, sponsored by Sansum Diabetes Research Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Sansum Diabetes Research Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

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

Among 22 studies in Diabetes Mellitus, Type 1 by Sansum Diabetes Research Institute — none open to participants now, none under way, none of them phase 3. Diabetes Mellitus, Type 1 · Sansum Diabetes Research Institute.

Enrollment
5th of 19
20 · median 14
Started
2017
with 1 other
No phase
11 of 22
none open now
Registered
14th of 22
by date

Among the 22 studies in Diabetes Mellitus, Type 1 by Sansum Diabetes Research Institute, this one is the 5th largest by enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2017, is one of 11 with no phase, and was the 14th 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

None of the 22 studies in Diabetes Mellitus, Type 1 by Sansum Diabetes Research Institute is open now.

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 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 22 studies in Diabetes Mellitus, Type 1 by Sansum Diabetes Research Institute as a file.
02

Study summary

This clinical trial will identify exercise-related and emotional stress related effects on glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.

Read the detailed description

Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.

03

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • type 1 diabetes
  • hypoglycemia
  • exercise
  • stress
  • artificial pancreas
  • cortisol
04

Who can participate

Ages eligible
18 Years to 75 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

  • Age 18-75 years
  • Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year.
  • Using an insulin pump for diabetes therapy for at least 3 months
  • Demonstration of proper mental status and cognition for the study
  • Non-smoker
  • If not currently using CGM, willing to use CGM during the study
  • An understanding of and willingness to follow the protocol and sign the

Exclusion criteria

Exclusion Criteria:

  • Admission for diabetic ketoacidosis in the 6 months prior to enrollment unless study team feels the subject is appropriate for study given complete clinical context for subject
  • Severe hypoglycemia resulting in seizure or loss of consciousness > once in the 6 months prior to enrollment
  • History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication
  • Cystic fibrosis
  • Unstable coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

    1. Inpatient psychiatric treatment in the past 6 months
    2. Presence of a known adrenal disorder or chronic oral therapy
    3. Abnormal liver function test results (Transaminase >3 times the ); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
    4. Abnormal renal function test results (calculated \<60 mL/min/1.73m2);
    5. Active gastroparesis (defined actively being treated with medications)
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
  • Abuse of alcohol or recreational drugs
  • Pregnancy
  • Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
  • Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening
  • Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
  • A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Terms in these criteria, in plain language(4)

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Observation of Exercise

    Observation During Exercise and Stress

    Other: Observation During Exercise and Stress

Interventions

  • OtherObservation During Exercise and Stress

    Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels. Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study.

06

What researchers measure

Primary outcomes

  1. Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl

    Examine the impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl. Correlate these factors that influence glycemic control to inform future algorithm development for an artificial pancreas (AP) device to better handle exercise and stress related events to be used in a future study.

    Time frame: 5 Weeks

Secondary outcomes

  1. CGM Glucose Levels 70-180 mg/dl

    CGM Glucose Levels, within target range 70-180 mg/dl

    Time frame: 5 Weeks

  2. CGM Glucose Levels less than 70 mg/dl

    CGM Glucose Levels, less than 70 mg/dl

    Time frame: 5 Weeks

  3. CGM Glucose Levels greater than 180 mg/dl

    CGM Glucose Levels, greater than 180 mg/dl

    Time frame: 5 Weeks

07

Study locations

2 sites
  • Sansum Diabetes Research Institute
    Santa Barbara, California 93111, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

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 Nov 2017 to primary completion in Aug 2018, 9 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 9 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
Oct 3, 2017
First posted
Oct 12, 2017
StartActual
Nov 1, 2017
Primary completionActual
Aug 31, 2018
CompletionActual
Aug 31, 2018
Last update
Sep 5, 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 Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03307850
Lead sponsor
Sansum Diabetes Research Institute
Collaborators
Mayo Clinic, Harvard University
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Nov 1, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Sep 5, 2018

Study contacts

Yogish C Kudva, MD
principal investigator · Mayo Clinic
Eyal Dassau, PhD
principal investigator · Harvard University
Jordan E Pinsker, MD
principal investigator · Sansum Diabetes Research Institute

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 Sep 2018. You cannot join it, but the record below documents what was studied.

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