Outpatient and Home-Use Clinical Trials

iLet™ Multi-PK Profiling Study

March 2019 – December 2019
The GEN3.2 iLet

Three 7-day iLet experiments in adults with T1D

  • Up to 30 subjects, each participating in three 7-day randomized cross-over treatment arms
  • One week with Humalog, one week with Novolog, and one week with BioChaperone® Lispro (BC222)
  • Must be ≥18 years old and remain within 250 miles of study base with no air travel
  • Home use study: People with T1D engaged in usual daily work and leisure routine
  • Realtime telemetric monitoring for hypoglycemia and hyperglycemia

Please visit our clinicaltrials.gov study record.

(not yet recruiting)

Fiasp® with iLet™ PK Exploratory Study

March 2019 – May 2019
The GEN3.2 iLet

Two 7-day iLet experiments in adults with T1D

  • Three cohorts, eight subjects per cohort, with each subject participating in two randomized cross-over treatment arms
  • Treatment arm 1: 7 days on the iLet with Fiasp using usual pharmacokinetic (PK) settings
  • Treatment arm 2: 7 days on the iLet with Fiasp using exploratory PK settings
  • Three days in a supervised study setting, 4 days in a home-use setting
  • Must live within 120 minutes of study base
  • Must have a screening A1c within 6.5-9%
  • Realtime telemetric monitoring for hypoglycemia and hyperglycemia

Please visit our clinicaltrials.gov study record.

(recruiting now)

The Bionic Pancreas Multi-Center Study

June 2014 – April 2015
The Bionic Pancreas Multi-Center Study

11-day experiments in adults with T1D

  • Randomized cross-over design (11 days on bionic pancreas, 11 days on usual care)
  • Home use study: People with T1D engaged in usual daily work and leisure routine
  • Must live within 30 minutes, stay within 60 minutes of study base
  • Sleep at home (with a designated contact), technical & medical support on call
  • Telemetry to monitor wireless connectivity of pumps and CGM, and if the CGM reads < 50 mg/dL
  • 40 adult subjects 18 years and older (440 bionic pancreas days)

Please visit our clinicaltrials.gov study record.

(complete, no longer enrolling)

2014 Summer Camp Study

July 2014 – August 2014
2014 Summer Camp Study

5-day experiments in pre-adolescents with T1D

  • Randomized cross-over design (5 days on bionic pancreas, 5 days on insulin pump therapy)
  • Integrated camp experience at Camp Joslin (boys) and Clara Barton Camp (girls)
  • Point of care capillary BG checks during day and night
  • Study staff and camp staff provide 24-hour coverage; round-the-clock telemetry to monitor wireless connectivity of pumps and CGM
  • 7 boys, 13 girls (6-11 years old) with T1D (120 bionic pancreas days)

Please visit our clinicaltrials.gov study record.

(complete, no longer enrolling)

2013 Summer Camp Study

July 2013 – August 2013
2013 Summer Camp Study

5-day experiments in adolescents with T1D

  • Randomized cross-over design (5 days on bionic pancreas, 5 days on insulin pump therapy)
  • Integrated camp experience at Camp Joslin (boys) and Clara Barton Camp (girls)
  • Point of care capillary BG checks during day and night
  • Study staff and camp staff provide 24-hour coverage; round-the-clock telemetry to monitor glycemia
  • 16 boys, 16 girls (12-20 years old) with T1D (160 bionic pancreas days)

Please visit our clinicaltrials.gov study record.
(complete, no longer enrolling)

The Beacon Hill Study

February 2013 – September 2013
The Beacon Hill Study

5-day experiments in adults with T1D

  • Randomized cross-over design (5 days on bionic pancreas, 5 days usual care)
  • Free run of Boston peninsula east of Mass Ave (three square mile area)
  • Point of care capillary BG checks during day, 1:1 nursing
  • Sleep in hotel with venous BG monitoring at night, 1:2 nursing
  • 20 adult subjects 21 years and older (100 bionic pancreas days)

Please visit our clinicaltrials.gov study record.
(complete, no longer enrolling)