Completed

SPT2DInsulin-Only Bionic Pancreas System for Type 2 Diabetes Management

Study Aim

This study aims to evaluate the effectiveness of an Insulin-Only Bionic Pancreas System in managing Type 2 Diabetes, focusing on the average time spent with glucose levels below 54 mg/dl and the mean glucose level as measured by a Dexcom CGM device.

What is being tested

Bionic Pancreas

+ Usual Care

DeviceOther

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years

+36 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2017

See protocol details

Summary

Principal SponsorMassachusetts General Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 28, 2017

Actual date on which the first participant was enrolled.

This study focuses on Type 2 Diabetes and aims to evaluate the safety and effectiveness of an insulin-only bionic pancreas system. This system is set at a specific point of 100 mg/dl. The study involves individuals who have Type 2 Diabetes. The main goal is to understand if this system can help improve blood sugar control, which is a common challenge in managing this condition. The study could potentially lead to better care and treatment options for people living with Type 2 Diabetes. The study is divided into two parts, each lasting for 7 days. One part involves usual care, while the other part involves using the insulin-only bionic pancreas system. The study measures the average blood sugar level and the time spent with low blood sugar levels, specifically less than 54 mg/dl. These measurements are taken from a device called Dexcom CGM and are collected during the last five days of each part. This is done to predict potential outcomes for long-term use. The first two days are not included to allow for the clearance of long-acting insulins.

Official TitleThe Set-Point Study for Type 2 Diabetes: Evaluating the Safety and Efficacy of an Insulin Only Bionic Pancreas System in Patients With Type 2 Diabetes

NCT03552523

Principal SponsorMassachusetts General Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

8 inclusion criteria required to participate

Age ≥18 years and clinical type 2 diabetes managed with:a multiple daily injection insulin regimen that includes NPH insulin and a rapid-acting insulin (insulin lispro, insulin aspart or insulin glulisine), an insulin pump filled with a rapid acting insulin, or a multiple daily injection insulin regimen that includes Lantus or Levemir and a rapid acting insulin.

Hemoglobin A1c >7%

Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)

Live within a 60 minute drive-time radius of the central monitoring location

Show More Criteria

28 exclusion criteria prevent from participating

Established history of allergy or severe reaction to adhesive or tape that must be used in the study

Unable to provide informed consent (e.g. impaired cognition or judgment)

Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.

Group II

Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Diabetes Research Center

Boston, United StatesOpen Diabetes Research Center in Google Maps

CompletedOne Study Center