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Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

NCTNCT02105324 (opens ClinicalTrials.gov in a new tab)Other id2014P000630
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 an outcome measure.

Overview

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

United States

Start
Jun 2014
Primary completion
Aug 2014
Completion
Aug 2014
First posted
7 Apr 2014 (estimated)
Last update posted
20 Oct 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
20142015
  1. N/A

    The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

    NCT02105324

    Jun 2014 to Aug 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 improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.

Interventions

  • Bionic PancreasDevice
  • Usual CareOther

Arms2

  • Experimental

    Bionic Pancreas

    Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.

  • Experimental

    Usual Care

    Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5

    Time frame · Days 2 to 5 of each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.

  2. Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5

    Time frame · Days 2 to 5 of each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL \[3.3 millimoles/liter (mmol/L)\] during Days 2 through 5 was calculated.

Secondary outcomes(20)

  1. Mean CGMG Values

    Time frame · Day 1 and Days 1-5 in each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.

  2. Percentage of Time With CGMG Concentration by Ranges During Day 1

    Time frame · Day 1 of each period

    Registry description

    Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dL(2.8 mmol/L), \< 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).

  3. Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5

    Time frame · Days 1 to 5 of each period

    Registry description

    Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dl (2.8 mmol/L), \< 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).

  4. Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5

    Time frame · Days 2 to 5 of each period

    Registry description

    Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: \< 50 mg/dl (2.8 mmol/L), \< 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).

  5. Percentage of Participants With Mean CGMG Glucose <154 mg/dL

    Time frame · Day 1, Days 1-5, and Days 2-5 of each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.

  6. Percentage of Participants With Mean CGMG Glucose <169 mg/dL

    Time frame · Day 1, Days 1-5, and Days 2-5 of each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.

  7. Percentage of Participants With Mean CGMG Glucose <183 mg/dL

    Time frame · Day 1, Days 1-5, and Days 2-5 of each period

    Registry description

    Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.

  8. Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)

    Time frame · Days 1-5

    Registry description

    A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of \< 70, \< 60, and \<50 mg/dL.

  9. Mean Plasma Glucose Values

    Time frame · Day 1, Days 1 to 5, and Days 2 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.

  10. Percentage of Time With Plasma Glucose Values by Ranges on Day 1

    Time frame · Day 1 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L).

  11. Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5

    Time frame · Days 1 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dL (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dL (2.8 mmol/L).

  12. Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5

    Time frame · Days 2 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L).

  13. Percentage of Participants With Mean Plasma Glucose <154 mg/dL

    Time frame · Day 1, Days 1 to 5, and Days 2 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.

  14. Percentage of Participants With Mean Plasma Glucose <169 mg/dL

    Time frame · Day 1, Days 1 to 5, and Days 2 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.

  15. Percentage of Participants With Mean Plasma Glucose <183 mg/dL

    Time frame · Day 1, Days 1 to 5, and Days 2 to 5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.

  16. Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)

    Time frame · Days 1-5

    Registry description

    A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of \< 70, \< 60, and \<50 mg/dL.

  17. Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care

    Time frame · Day 1, Days 1-5, and Days 2-5 of the Usual Care Period

    Registry description

    The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.

  18. Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL

    Time frame · Day 1, Days 1-5, and Days 2-5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.

  19. Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL

    Time frame · Day 1, Days 1-5, and Days 2-5 of each period

    Registry description

    Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.

  20. Insulin Total Daily Dose

    Time frame · 11 days

    Registry description

    Insulin total daily dose is reported in units per kilogram per day (U/kg/day).

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· Days 2 to 5 of each period

Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5

GroupValue (milligrams/deciliter (mg/dL))Spread
Bionic Pancreas136.810.8
Usual Care167.430.6
Primary outcomeMean· Days 2 to 5 of each period

Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5

GroupValue (percentage of time)Spread
Bionic Pancreas1.21.1
Usual Care2.81.2
Secondary and other outcome results(6)
Secondary outcomeMean· Day 1 and Days 1-5 in each period

Mean CGMG Values

GroupValue (mg/dL)Spread
Bionic Pancreas153.619.7
Usual Care179.237.8
Secondary outcomeMean· Day 1 of each period

Percentage of Time With CGMG Concentration by Ranges During Day 1

GroupValue (percentage of time)Spread
Bionic Pancreas0.20.6
Usual Care1.02.6
Secondary outcomeMean· Days 1 to 5 of each period

Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5

GroupValue (percentage of time)Spread
Bionic Pancreas0.40.4
Usual Care1.10.8
Secondary outcomeMean· Days 2 to 5 of each period

Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5

GroupValue (percentage of time)Spread
Bionic Pancreas0.40.5
Usual Care1.10.8
Secondary outcomeNumber· Day 1, Days 1-5, and Days 2-5 of each period

Percentage of Participants With Mean CGMG Glucose <154 mg/dL

GroupValue (percentage of participants)
Bionic Pancreas57.9
Usual Care15.8
Secondary outcomeNumber· Day 1, Days 1-5, and Days 2-5 of each period

Percentage of Participants With Mean CGMG Glucose <169 mg/dL

GroupValue (percentage of participants)
Bionic Pancreas89.5
Usual Care36.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Bionic PancreasBionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.–0 / 1915 / 19
Usual CareUsual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.–0 / 1913 / 19

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, Hillard MA, Balliro C, Magyar KL, Selagamsetty R, Sinha M, Grennan K, Mondesir D, Ekhlaspour L, Zheng H, Damiano ER, El-Khatib FH. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):233-243. doi: 10.1016/S2213-8587(15)00489-1. Epub 2016 Feb 3. PMID 26850709

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria * Age 6-11 years with type 1 diabetes for at least one year * Diabetes managed using an insulin infusion pump for ≥ three months * Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily) * 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 consent, informed assent or parental consent * Unable to comply with study procedures * Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis) * Pregnancy (positive urine human chorionic gonadotropin \[HCG\]) * History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion * Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma * History of prolonged QT or arrhythmia, 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 (T1D) at the time of the study * Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants * 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 radio-frequency (RF) interference * Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications * History of adverse reaction to glucagon (including allergy) besides nausea and vomiting. * Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of the study * History of eating disorder such as anorexia, bulimia, or 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

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