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

Type 1 Diabetes Clinical Trial

Official title:

The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01833988
• Other study ID #: 2013p000561
• Status: Active, not recruiting
• Phase: N/A
• First received: April 13, 2013
• Last updated: March 11, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 20 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Bi-hormonal Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean absolute relative deviation (MARD) of CGMG vs. scheduled HemoCue BG measurements in closed-loop and usual care periods		1 week	No
Other	Difference between closed-loop and open-loop in mean insulin total daily dose		1 week	No
Other	Fraction of time bionic pancreas not functioning properly due to: system crash, communication problem (continuous glucose monitor), communication problem (pumps), pump malfunction, tubing occlusion, infusion set failure)		1 week	Yes
Other	Difference of outcome measures on day 1 vs. remaining days (days 2-5) and on day 1-2 vs. on remaining days (days 3-5) for both closed-loop and usual care		1 week	No
Primary	Difference in average blood glucose (BG) between closed-loop and open-loop periods as determined from all scheduled HemoCue measurements with mean evenly weighted across the daytime and nighttime hours.		1 week	No
Primary	Difference between closed-loop and open-loop in the percentage of the above subset of BG values less than 70 mg/dl.		1 week	Yes
Secondary	Difference between closed-loop and open-loop 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.		1 week	No
Secondary	Difference between closed-loop and open-loop in percentage of the above subset of BG values less than 70 mg/dl.		1 week	Yes
Secondary	Difference between closed-loop and open-loop in average BG as determined from the pre-meal, pre-snack, before bed, 12:00 AM, and 3:45 AM HemoCue measurements (nine measurements per day)		1 week	No
Secondary	Difference between closed-loop and open-loop in the percentage of the above subset of BG values between the closed-loop control and usual care periods less than 70 mg/dl.		1 week	Yes
Secondary	Difference between closed-loop and open-loop in percentage of subjects with mean BG < 154 mg/dl		1 week	No
Secondary	Difference in the percentage of study days with mean BG < 154 mg/dl over the duration of the closed-loop period vs. the usual care period		1 week	No
Secondary	Difference between closed-loop and open-loop in number of hypoglycemic events as determined from HemoCue measurements		1 week	Yes
Secondary	Difference between closed-loop and open-loop in fraction of time spent within glucose ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)		1 week	Yes
Secondary	Difference between closed-loop and open-loop in mean BG during exercise		1 week	No
Secondary	Difference between closed-loop and open-loop in number of hypoglycemic episodes and nadir BG during exercise		1 week	Yes
Secondary	Difference between closed-loop and open-loop in mean BG and likelihood of hypoglycemia on nights after a period of exercise > 30 minutes vs. nights after days without exercise		1 week	Yes
Secondary	Difference of outcome measures on day 1 vs. remaining days (days 2-5) and on day 1-2 vs. on remaining days (days 3-5) in closed-loop and usual care periods		1 week	No
Secondary	Difference between closed-loop and open-loop in mean continuous glucose monitoring glucose (CGMG)		1 week	No
Secondary	Difference between closed-loop and open-loop in number of CGMG events < 70 mg/dl (episodes separated by < 15 minutes will be considered a single episode) and nadir for each		1 week	Yes
Secondary	Difference between closed-loop and open-loop in fraction of time spent within CGMG ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)		1 week	Yes
Secondary	Difference between closed-loop and open-loop in area over the curve and below 70 mg/dl (measure of total hypoglycemia exposure)		1 week	Yes
Secondary	Difference between closed-loop and open-loop in area over the curve and below 50 mg/dl (measure of total hypoglycemia exposure)		1 week	Yes
Secondary	Difference between closed-loop and open-loop in percentage of subjects with mean CGMG < 154 mg/dl		1 week	No
Secondary	Difference between closed-loop and open-loop in percentage of study days with mean CGMG < 154 mg/dl		1 week	No
Secondary	Difference between closed-loop and open-loop in mean CGMG in the four hour period following meals		1 week	No
Secondary	Difference between closed-loop and open-loop in mean CGMG during exercise		1 week	No
Secondary	Difference between closed-loop and open-loop in number of incidents of hypoglycemia and nadir CGMG during exercise		1 week	Yes
Secondary	Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability)		1 week	No
Secondary	Difference between closed-loop and open-loop in standard deviation of CGMG values at night (11:00 PM to 7:00 AM)		1 week	No
Secondary	Difference between closed-loop and open-loop in average BG as determined from all HemoCue measurements taken during the daytime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.		1 week	No
Secondary	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.		1 week	No
Secondary	Difference between closed-loop and open-loop in percentage of the above subset of BG values at night less than 70 mg/dl.		1 week	Yes
Secondary	Difference between closed-loop and open-loop in number of hypoglycemic events at night as determined from HemoCue measurements		1 week	Yes
Secondary	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)		1 week	Yes
Secondary	Difference between closed-loop and open-loop in mean CGMG at night		1 week	No
Secondary	Difference between closed-loop and open-loop in number of CGMG events < 70 mg/dl (episodes separated by < 15 minutes will be considered a single episode) and nadir for each during nighttime hours		1 week	Yes
Secondary	Difference between closed-loop and open-loop in fraction of time spent within CGMG ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at night		1 week	Yes
Secondary	Difference between closed-loop and open-loop in area over the curve and below 70 mg/dl (measure of total hypoglycemia exposure) at night		1 week	Yes
Secondary	Difference between closed-loop and open-loop in area over the curve and below 50 mg/dl (measure of total hypoglycemia exposure) at night		1 week	Yes
Secondary	Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability) at night		1 week	No
Secondary	Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia		1 week	Yes
Secondary	Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia at night		1 week	Yes
Secondary	Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia		1 week	Yes
Secondary	Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia at night		1 week	Yes

External Links

•   Information about this and related studies