NCT01833988

Brief Summary

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 11, 2017

Completed
Last Updated

September 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

April 13, 2013

Results QC Date

September 10, 2015

Last Update Submit

August 10, 2017

Conditions

Type 1 Diabetes

Keywords

bionic pancreasartificial pancreasinsulinglucagoncontinuous glucose monitoring (CGM)outpatientinsulin pumppediatricschildrencampsummer camp

Outcome Measures

Primary Outcomes (2)

  • Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.

    1 week

  • Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm

    1 week

Secondary Outcomes (25)

  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.

    1 week

  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl

    Day 2-5

  • Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period

    Day 2-5

  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements

    Day 1-5

  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)

    1 week

  • +20 more secondary outcomes

Other Outcomes (1)

  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose

    1 week

Study Arms (2)

Bi-hormonal Bionic Pancreas

EXPERIMENTAL

Bi-hormonal Bionic Pancreas

Device: Bi-hormonal Bionic Pancreas

Usual Care

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

Bi-hormonal Bionic PancreasDEVICE

Automated blood glucose control via a closed-loop bionic pancreas device.

Also known as: Boston University Bionic Pancreas
Bi-hormonal Bionic Pancreas
Usual CareOTHER

Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Usual Care

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-20 years with type 1 diabetes for at least one year.
  • Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.

You may not qualify if:

  • Unable to provide informed assent
  • Unable to comply with study procedures.
  • Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
  • Total daily dose (TDD) of insulin that is \> 2 units/kg.
  • Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
  • Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is \< 50 mg/dl)
  • End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
  • History of prolonged QT or arrhythmia
  • History of congenital heart disease or current known cardiac disease
  • Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study.
  • Seizure disorder or history of hypoglycemic seizures or coma in the last five years
  • Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference.
  • Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications.
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.

    PMID: 24931572DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin ResistanceMuscle Cramp

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinismMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Steven J. Russell
Organization
Massachusetts General Hospital Diabetes Research Center
sjrussell@partners.org
617.726.1848

Study Officials

  • Steven J Russell, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 13, 2013

First Posted

April 17, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2014

Last Updated

September 8, 2017

Results First Posted

August 11, 2017

Record last verified: 2017-08

Locations

US(1)