NCT01787318

Brief Summary

This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

January 16, 2013

Last Update Submit

April 13, 2016

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Peak Post-Prandial Glucose Excursions

    Peak post-prandial plasma glucose excursions after breakfast, lunch, and dinner on days #2 and #3. One day with InsuPatch activated and one day without InsuPatch activated

    48 hours

Secondary Outcomes (6)

  • Total Area Under Curve of the meal-related glucose excursion over target

    48 hours

  • Nadir glucose levels following the meals

    48 hours

  • Mean 24 hour glucose levels

    48 hours

  • Mean daytime and nighttime glucose levels

    48 hours

  • Peak post-prandial insulin levels following meals

    48 hours

  • +1 more secondary outcomes

Study Arms (2)

ePID closed loop system using Insupatch

EXPERIMENTAL

Insupatch activated at mealtimes

Device: ePID closed loop systemDevice: InsuPatch

ePID closed loop system without InsuPatch

ACTIVE COMPARATOR

InsuPatch will not be activated at mealtimes

Device: ePID closed loop system

Interventions

ePID closed loop systemDEVICE

Insulin pump controlled by closed loop unit and algorithm

ePID closed loop system using InsupatchePID closed loop system without InsuPatch
InsuPatchDEVICE

device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site

ePID closed loop system using Insupatch

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 12-40 years
  • clinical diagnosis of type 1 diabetes
  • duration of type 1 diabetes ≥ 1 year
  • HbA1c ≤ 9 %
  • Treated with pump therapy for at least 3 months
  • Body weight \> 40 kg

You may not qualify if:

  • 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 blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission. 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 poor wound healing, heat sensitivity, or diminished skin integrity.
  • History of hypoglycemic seizure within last 3 months
  • Anemic (low hematocrit), or evidence of renal insufficiency (elevated serum creatinine)
  • Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
  • Subjects unable to give consent / permission / assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Stuart Weinzimer, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

February 8, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

US(1)