The 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

Massachusetts General Hospital1 site in 1 country16 target enrollmentJuly 28, 2017

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Massachusetts General Hospital
Enrollment: 16
Locations: 1
Primary Endpoint: Mean Dexcom CGM Glucose (CGMG) Level
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Our goal is to conduct an outpatient study testing the bionic pancreas in the insulin-only configuration at a set-point of 100 mg/dl in 10 adult (≥ 18 years of age) subjects with type 2 diabetes in a random-order crossover study versus usual care with daily injections or an insulin pump.

Detailed Description

The study will consist of two 7 day study arms: one usual care, and one insulin-only bionic pancreas at a set point of 100 mg/dl. The co-primary outcomes will be the mean Dexcom CGM glucose level and time \<54 mg/dl, both in the last five days of each arm because these will be predictive of outcomes in long term use. The first two days will be excluded to allow for the extended washout of long acting insulins.

Registry

clinicaltrials.gov

Start Date

July 28, 2017

End Date

March 29, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Steven J. Russell, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes group: 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
•Willing to remain within a 120 minute drive-time radius of the central monitoring location throughout the study
•Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)
•Willing to wear one infusion set and one Dexcom CGM sensor and change sets frequently (an insulin infusion set every other day throughout the study) Have a mobile phone they are willing to keep with them and answer calls from study staff.

Exclusion Criteria

•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
•Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study. Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
•Need to go outside of the designated geographic boundaries during the study
•Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
•Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
•Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
•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.
•Renal failure on dialysis