ClinicalTrials.gg
CompletedNCT01490151Updated Sep 29, 2017Results posted

Medtronic Treat to Range (TTR) Closed-Loop Control

An interventional study of TTR controller (Medtronic) in Diabetes Mellitus, Type 1 Diabetes and Metabolic and Nutritional Disorders, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 15 Years to 30 Years. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
15 Years to 30 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.

Read the detailed description

The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.

02

Conditions studied

  • Diabetes Mellitus
  • Type 1 Diabetes
  • Metabolic and Nutritional Disorders

Keywords

  • Hormone
  • Diabetes
  • Mellitus
  • Type 1
  • Immune
  • Metabolic disorder
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.

Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 30 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. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
  2. Age 15 years to less than 30 years old.
  3. HbA1c \< 10%.
  4. Subject has used a downloadable insulin pump for at least 3 months.
  5. Parent/guardian and subject understand the study protocol and agree to comply with it.
  6. Subject comprehends written English.
  7. Subject has a home computer with email access.
  8. For females, subject not intending to become pregnant during the study.
  9. No expectation that subject will be moving out of the area of the clinical center during the study.
  10. Informed Consent Form signed by the subject or guardian.
  11. Subjects cannot have had a severe hypoglycemic event described as a seizure, loss of consciousness requiring an emergency department visit or hospitalization within 6 months of enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Asthma if treated with systemic or inhaled corticosteroids in the last 6 months; Subject has taken oral or injectable corticosteroids within the last 30 days; Current use of oral/inhaled Glucocorticoids
  2. Cystic fibrosis
  3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
  4. Use of non-insulin medications that may affect blood glucose (eg Symlin),
  5. Systolic blood pressure >140 on screening; Diastolic blood pressure >90 on screening
  6. History of seizure or loss of consciousness in the last 6 months.
  7. Adhesive allergies; Active skin condition that would affect sensor placement
  8. History of heart disease
  9. Active Graves disease;
  10. Currently on beta blocker medication;
  11. Unwilling or unable to follow the protocol;
  12. History of diagnosed medical eating disorder;
  13. History of known illicit drug abuse or prescription drug abuse;
  14. History of current alcohol abuse;
  15. History of visual impairment which would not allow subject to participate
  16. Currently participating in an investigational study (drug or device);
  17. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
05

Study design

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

Study arms

  • Experimental
    TTR controller

    The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals

    Device: TTR controller (Medtronic)

Interventions

  • DeviceTTR controller (Medtronic)

    Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.

06

What researchers measure

Primary outcomes

  1. Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions

    A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.

    Time frame: Day of hospital admission (12 hours)

07

Results

Posted Sep 29, 2017

Participant flow

Participant flow — Overall Study
MilestoneTTR Controller
Started22
Completed22
Not completed0

Outcome measures

PrimarySafety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions

A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.

Time frame:
Day of hospital admission (12 hours)
Reported as:
Count of units · Admissions
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
AdmissionsCohort A1 - Missed Bolus MealCohort A2 - Missed Bolus MealCohort B - Overbolus Meal
Successful Admission747
Unsuccessful Admission232

Adverse events

Collected over Day of hospital admission (12 hours). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TTR Controller—0/22 (0%)6/22 (27.3%)
Most frequent other events
Most frequent other events
EventTTR Controller
HypoglycemiaMetabolism and nutrition disorders6/22
Hypoglycemia <50 mg/dLMetabolism and nutrition disorders2/22
Significant Post-Prandial HyperglycemiaMetabolism and nutrition disorders1/22

Baseline characteristics

Subjects with Type 1 Diabetes

Age, Categorical
Age, Categorical(Participants)TTR Controller
<=18 years6
Between 18 and 65 years16
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)TTR Controller
Female13
Male9
08

Study locations

1 site
  • Stanford University and Stanford Hospital & Clinics
    Stanford, California 94305, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01490151
Collaborators
Medtronic
Responsible party
Bruce A. Buckingham (Director, Pediatric Endocrinology, Stanford University) — Principal investigator
First posted
Dec 12, 2011
Start date
Dec 2011
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Sep 29, 2017
Last update
Sep 29, 2017

Study contacts

Bruce Buckingham, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion