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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: Bi-hormonal Bionic Pancreas (Device); Usual Care (Other)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven J Russell, MD PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

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.

Clinical Details

Official title: The Summer Camp Study 2: Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population Ages 6-11 at the Clara Barton Diabetes Camps

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

Primary outcome:

Mean CGM glucose values during days 2-5

Fraction of time with CGM glucose < 60 mg/dl during days 2-5

Secondary outcome:

Mean CGM glucose

Fraction of time spent within CGMG ranges (<50, <60,< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl).

Percentage of subjects with mean CGMG < 154 mg/dl.

Percentage of subjects with mean CGMG < 169 mg/dl.

Percentage of subjects with mean CGMG < 183 mg/dl.

Number of CGMG reported hypoglycemic events (< 70 mg/dl, < 60 mg/dl, <50 mg/dl).

Average BG determined from the scheduled StatStrip Xpress measurements.

Percentage of the scheduled StatStrip Xpress BG values < 70 mg/dl, < 60 mg/dl, and < 50 mg/dl.

Percentage of subjects with mean BG < 154 mg/dl, < 169 mg/dl, and < 183 mg/dl using the scheduled StatStrip Xpress measurements.

Number of hypoglycemic events (BG < 70 mg/dl, BG < 60 mg/dl, BG < 50 mg/dl) as determined from all StatStrip Xpress measurements.

Fraction of days CGM used by participants in the usual care arm.

Number of carbohydrate interventions for hypoglycemia when BG < 70 mg/dl.

Grams of carbohydrate taken for hypoglycemia when BG < 70 mg/dl.

Mean insulin total daily dose.

Mean glucagon total daily dose.

Mean daily basal insulin dose.

Mean daily bolus insulin dose.

Mean meal carbohydrate content.

Number of unscheduled infusion set changes.

Number and severity of local infusion site reactions.

Episodes of nausea and nausea index as determined by VAS

Number of severe hypoglycemic events.

Time subjects were not under bionic pancreas control during the bionic pancreas arm.

Time without CGM monitoring data during the usual care arm

Change in body weight from beginning to end of each study arm

Reliability index

List of technical faults associated with the bionic pancreas including cause and resolution

Eligibility

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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 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 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 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 RF interference

- Use of oral (e. g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4

inhibitors, 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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Information about this and related studies

Starting date: June 2014
Last updated: January 22, 2015

Page last updated: August 23, 2015

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