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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

NCTNCT01762059 (opens ClinicalTrials.gov in a new tab)Other id2012P002317
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Not applicable
Enrollment
32 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2013
Primary completion
Oct 2013
Completion
Jun 2014
First posted
7 Jan 2013 (estimated)
Last update posted
21 Jul 2017
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. N/A

    Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

    NCT01762059

    Jan 2013 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 in the outpatient environment.

Interventions

  • Bi-homonal Bionic PancreasDevice
  • Usual careOther

Arms2

  • Experimental

    Bi-homonal Bionic Pancreas

    Closed-loop blood glucose control with a bi-hormonal bionic endocrine pancreas designed by Edward Damiano and Firas El-Khatib of Boston University. The device will deliver insulin lispro (Humalog) and glucagon based on blood glucose levels estimated by a continuous glucose monitoring device (Dexcom G4 Platinum) and a proprietary dosing algorithm. Blood glucose control will be automated for 5 days during which volunteers will sleep in a hotel and roam freely in downtown Boston during the day. There will be no restrictions on diet or exercise.

  • Active comparator

    Usual Care

    Usual care for 5 days (insulin pump therapy according to usual practice), volunteers will sleep at home and maintain their usual schedule during the day, there will be no restrictions on diet or exercise, they will wear a blinded CGM

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Average Blood Glucose (Co-primary Outcome)

    Time frame · 5 days of closed-loop control

    Registry description

    Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).

  2. Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)

    Time frame · 5 days

    Registry description

    Percentage of time blood glucose values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime) during day 1-5. During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm

Secondary outcomes(15)

  1. Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.

    Time frame · 5 days

    Registry description

    During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm

  2. Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.

    Time frame · 5 days

  3. Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.

    Time frame · 5 days

  4. Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.

    Time frame · 5 days

  5. Percentage of Subjects With Mean BG < 154 mg/dl.

    Time frame · 5 days

    Registry description

    This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

  6. Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.

    Time frame · 5 days

  7. Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements.

    Time frame · 5 days

  8. Nadir BG During Exercise.

    Time frame · 5 days

  9. Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event

    Time frame · 5 days

  10. Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.

    Time frame · 5 days

    Registry description

    This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.

  11. Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements.

    Time frame · 5 Days

    Registry description

    Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean): \< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, \>180 mg/dl, \>250 mg/dl

  12. Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period.

    Time frame · 5 Days

  13. Mean BG During Exercise.

    Time frame · 5 days

  14. Number of Hypoglycemic Episodes During Exercise.

    Time frame · 5 days

  15. Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period.

    Time frame · 5 Days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 5 days of closed-loop control

Average Blood Glucose (Co-primary Outcome)

GroupValue (mg/dL)Spread
Bionic Pancreas13814
Primary outcomeMean· 5 days

Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)

GroupValue (percentage of time)Spread
Bionic Pancreas4.85.2
Secondary and other outcome results(6)
Secondary outcomeMean· 5 days

Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.

GroupValue (mg/dl)Spread
Bi-homonal Bionic Pancreas13814
Secondary outcomeMean· 5 days

Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.

GroupValue (percentage of time)Spread
All Participants: Bi-hormonal Bionic Pancreas and Usual Care4.85.2
Secondary outcome· 5 days

Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.

GroupValue
All Participantsnot posted
Secondary outcome· 5 days

Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.

GroupValue
All Participantsnot posted
Secondary outcomeNumber· 5 days

Percentage of Subjects With Mean BG < 154 mg/dl.

GroupValue (percentage of participants)
Bionic Pancreas100
Secondary outcome· 5 days

Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.

GroupValue
All Participantsnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bionic Pancreas (Closed Loop)–0 / 208 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedRussell 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 24931572

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 21 years or older with type 1 diabetes for at least one year * Stimulated C-peptide \< 0.1 nmol/L at 90 minutes after liquid mixed meal by the DCCT protocol * 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 * Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled) Exclusion Criteria: * Unable to provide informed consent * Unable to comply with study procedures * Total daily dose (TDD) of insulin that is \> 1.5 U/kg * Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when BG is \< 50 mg/dl) * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * Any known history of coronary artery disease (CAD) * Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia * Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea). * History of TIA or stroke. * History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor * Untreated or inadequately treated mental illness * Current alcohol abuse or substance abuse * Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference. * Use non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications * History of adverse reaction to glucagon (including allergy) besides nausea and vomiting * Unwilling or unable to completely avoid acetaminophen * ALT \> 3-fold upper limit of normal * Albumin \< 3 g/dl * Body mass index less than18 or greater than 35

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