Skip to content

Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas

NCTNCT01833988 (opens ClinicalTrials.gov in a new tab)Other id2013p000561
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
Apr 2013
Primary completion
Aug 2013
Completion
Dec 2014
First posted
17 Apr 2013 (estimated)
Last update posted
8 Sept 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

    The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas

    NCT01833988

    Apr 2013 to Dec 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 care for young people with type 1 diabetes 12-20 in a diabetes camp environment.

Interventions

  • Bi-hormonal Bionic PancreasDevice
  • Usual CareOther

Arms2

  • Experimental

    Bi-hormonal Bionic Pancreas

    Bi-hormonal Bionic Pancreas

  • Active comparator

    Usual Care

    Usual Care

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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.

    Time frame · 1 week

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

    Time frame · 1 week

Secondary outcomes(20)

  1. 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.

    Time frame · 1 week

    Registry description

    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 taken before meals, taken during exercise, and taken for hypoglycemia monitoring.

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

    Time frame · Day 2-5

  3. 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

    Time frame · Day 2-5

  4. 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

    Time frame · Day 1-5

  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)

    Time frame · 1 week

  6. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise

    Time frame · 1 week

  7. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise

    Time frame · 1 week

  8. Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)

    Time frame · 1 week

  9. Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)

    Time frame · Day 2-5

    Registry description

    Day 2-5

  10. Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)

    Time frame · 1 week

  11. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)

    Time frame · 1 week

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

    Time frame · 1 week

  13. Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals

    Time frame · 1 week

  14. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise

    Time frame · 1 week

  15. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.

    Time frame · 1 week

    Registry description

    Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges. %\<70 70-120 70-180 %\>180 %\>250

  16. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)

    Time frame · 1 week

  17. Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.

    Time frame · 1 week

  18. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night

    Time frame · 1 week

  19. Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)

    Time frame · 1 week

  20. Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night

    Time frame · Day 2-5

    Registry description

    Day 2-5

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· 1 week

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.

GroupValue (mg/dL)Spread
Bionic Pancreas13818
Control15727
Primary outcomeMean· 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

GroupValue (percentage of time)Spread
Bionic Pancreas6.14.5
Standard Care (Insulin Pump)7.67.3
Secondary and other outcome results(6)
Secondary outcome· 1 week

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.

GroupValue
Bionic Pancreasnot posted
Secondary outcomeCount of participants· Day 2-5

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

GroupValue (Participants)
Bi-hormonal Bionic Pancreas29
Usual Care14
Secondary outcomeMean· 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

GroupValue (percentage of days)Spread
Bi-hormonal Bionic Pancreas7521.5
Usual Care49.336.2
Secondary outcomeNumber· Day 1-5

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

GroupValue (events)
Bi-hormonal Bionic Pancreas97
Usual Care210
Secondary outcomeMean· 1 week

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)

GroupValue (percentage of time)Spread
Bi-hormonal Bionic Pancreas2.72.2
Usual Care5.34.6
Secondary outcome· 1 week

Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise

GroupValue
Bi-hormonal Bionic Pancreasnot posted
Usual Carenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bionic Pancreas–0 / 326 / 32
Control–0 / 324 / 32

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 12 Years up to 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. * Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion). Exclusion Criteria: * 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. * Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study. * History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight * History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment * Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.

PepBank is a research reference. Talk to a doctor before you use any peptide.