NCT02969863

The Monitoring Study

Completed NA Results posted Last updated 30 July 2018

What this trial tests

NA trial testing Bihormonal Bionic Pancreas in Type1diabetes in 27 participants. Completed in 28 December 2017.

Timeline

1 April 2017

Primary endpoint
1 June 2017

28 December 2017

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 April 2017
Primary completion	1 June 2017
Estimated completion	28 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Bihormonal Bionic Pancreas
• Insulin Only Bionic Pancreas
• Monitored for Hypoglycemia
• Not Monitored for Hypoglycemia

Conditions studied

• Type1diabetes — all drugs for Type1diabetes →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time Spent With Dexcom CGMG < 60 mg/dl Primary · days 2-7

A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl

Group	Value	95% CI
Usual Care Arm - Monitored	1.32	± 1.39
Usual Care Arm - Unmonitored	1.95	± 2.11
Bihormonal Bionic Pancreas - Monitored	1.05	± 1.01
Bihormonal Bionic Pancreas - Unmonitored	0.99	± 0.93
Insulin Only Bionic Pancreas - Monitored	1.55	± 1.16
Insulin Only Bionic Pancreas - Unmonitored	1.66	± 1.33

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care Arm - Monitored

Serious: 1/24 (4%)

Deaths: 0/24

Usual Care Arm - Unmonitored

Serious: 0/24 (0%)

Deaths: 0/24

Bihormonal Bionic Pancreas - Monitored

Serious: 0/24 (0%)

Deaths: 0/24

Bihormonal Bionic Pancreas - Unmonitored

Serious: 0/24 (0%)

Deaths: 0/24

Insulin Only Bionic Pancreas - Monitored

Serious: 0/24 (0%)

Deaths: 0/24

Insulin Only Bionic Pancreas - Unmonitored

Serious: 0/24 (0%)

Deaths: 0/24

Serious adverse events (1 terms)

Reaction	System	Usual Care Arm - Monitored	Usual Care Arm - Unmonitored	Bihormonal Bionic Pancreas…	Bihormonal Bionic Pancreas…	Insulin Only Bionic Pancre…	Insulin Only Bionic Pancre…
Hypoglycemia	Endocrine disorders	—	—	—	—	—	—

Most-reported serious reactions: Hypoglycemia.

Data from ClinicalTrials.gov NCT02969863 adverse events section.

Sponsor's own description

To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study versus usual care with an insulin pump with and without remote monitoring of hypoglycemia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.