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

Type 1 Diabetes Clinical Trial

Official title:

The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01762059
• Other study ID #: 2012P002317
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 21, 2012
• Last updated: December 4, 2013
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• 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 in the outpatient environment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Bi-homonal Bionic Pancreas
A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.

Other:
• Usual care

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	Number of CGMG events <70mg/dl.		5 days	Yes
Other	Percentage of subjects with mean CGMG < 154mg/dl		5 days	Yes
Other	Difference in the percentage of subjects with mean CGMG <154mg/dl during the closed-loop period vs. the usual care period		5 days	No
Other	Nadir CGMG during exercise.		5 days	Yes
Other	Correlation between exercise intensity and likelihood of a hypoglycemic event by CGMG		5 days	Yes
Other	Fraction of time spent within each of the following glucose ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl		5 Days	Yes
Other	Mean absolute relative deviation (MARD) vs. subset of HemoCue and GlucoScout BG measurements taken every two hours during the closed-loop period		5 Days	Yes
Other	Mean absolute relative deviation (MARD) vs. HemoCue BG measurements taken during the usual care period		5 Days	Yes
Other	MARD vs. all HemoCue BG measurements (daytime)		5 Days	No
Other	MARD vs. all GlucoScout BG measurements during the closed-loop period (nighttime)		5 Days	Yes
Other	MARD vs. all BG measurements (both HemoCue and GlucoScout) during the closed-loop period		5 Days	Yes
Other	Total number of grams of carbohydrate taken for hypoglycemia (day and night) during the closed-loop vs. usual care periods.		5 Days	Yes
Other	Mean daily bolus insulin dose for the usual care vs. the closed-loop periods		5 Days	No
Other	Total number of grams of carbohydrate taken for hypoglycemia during the daytime (7:00 AM - 11:00 PM)of the closed-loop period.		5 Days	No
Other	Total number of grams of carbohydrate taken for hypoglycemia overnight(11:00 PM - 7:00 AM)of the closed-loop period.		5 Days	No
Other	Difference in mean insulin dosing during the four hour period after a meal during periods of normal operation vs. periods of bionic pancreas downtime (open-loop dosing)		5 Days	Yes
Other	Mean CGMG.		5 days	Yes
Other	Total number of grams of carbohydrate taken for hypoglycemia (day and night) during usual care period vs the closed-loop period.		5 Days	Yes
Other	Insulin total daily dose during the usual care vs. the closed-loop periods.		5 Days	No
Other	Daily basal insulin dose for the usual care vs the closed-loop periods.		5 Days	No
Other	Number of carbohydrate interventions for hypoglycemia during the daytime (7:00 AM - 11:00 PM)of the closed-loop period.		5 Days	No
Other	Number of incidents of hypoglycemia during exercise.		5 days	Yes
Other	Number of carbohydrate interventions for hypoglycemia overnight (11:00PM-7:00AM) during the closed-loop period.		5 Days	No
Other	CGMG nadir.		5 days	Yes
Primary	Average BG (co-primary outcome)	Average BG during the closed-loop control period as determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime).	5 days of closed-loop control	Yes
Primary	Percentage of BG values less than 70 mg/dl (co-primary outcome)	Percentage of BG values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime).	5 days	Yes
Secondary	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.		5 days	Yes
Secondary	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.		5 days	Yes
Secondary	Difference in the average BG between the closed-loop control period and the usual care period.		5 days	No
Secondary	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.		5 days	Yes
Secondary	Percentage of subjects with mean BG < 154 mg/dl.		5 days	No
Secondary	Difference in the percentage of subjects with mean BG < 154 mg/dl during the closed-loop period vs. the usual care period.		5 days	No
Secondary	Number of hypoglycemic events as determined from GlucoScout and HemoCue measurements.		5 days	Yes
Secondary	Nadir BG during exercise.		5 days	Yes
Secondary	Correlation between exercise intensity and likelihood of a hypoglycemic event		5 days	Yes
Secondary	Average BG during the closed-loop control period as determined from all GlucoScout measurements taken during the nighttime monitoring.		5 days	Yes
Secondary	Fraction of time spent within each of the following glucose ranges as determined from all GlucoScout and HemoCue measurements.	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	5 Days	Yes
Secondary	Difference of outcome measures on days 1-2 vs. on remaining days (days 3-5) during the closed-loop period.		5 Days	Yes
Secondary	Mean BG during exercise.		5 days	Yes
Secondary	Number of hypoglycemic episodes during exercise.		5 days	Yes
Secondary	Difference of outcome measures on day 1 vs. remaining days (days 2-5) during the closed-loop period.		5 Days	Yes

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