The Monitoring Study
1 other identifier
interventional
27
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2017
CompletedResults Posted
Study results publicly available
July 30, 2018
CompletedJuly 30, 2018
July 1, 2018
2 months
November 18, 2016
February 7, 2018
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Time Spent With Dexcom CGMG < 60 mg/dl
A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl
days 2-7
Study Arms (6)
Usual Care Arm - Monitored
ACTIVE COMPARATORSubjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia
Usual Care Arm - Unmonitored
ACTIVE COMPARATORSubjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia
Bihormonal Bionic Pancreas - Monitored
EXPERIMENTALSubjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia
Bihormonal Bionic Pancreas - Unmonitored
EXPERIMENTALSubjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia
Insulin Only Bionic Pancreas - Monitored
EXPERIMENTALSubjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia
Insulin Only Bionic Pancreas - Unmonitored
EXPERIMENTALSubjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia
Interventions
Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.
Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.
During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.
During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year managed using an insulin pump for ≥ 6 months
- 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 or two infusion sets and one Dexcom CGM sensor and change sets frequently (at least one new glucagon infusion set daily during bi-hormonal arms, and insulin infusion set every other day throughout the study)
- Willing to wear two additional CGM sensors that must be placed in the upper arm
You may not qualify if:
- 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
- Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease
- Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)
- Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
- History of TIA or stroke
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MGH Diabetes Research Center
Boston, Massachusetts, 02114, United States
Results Point of Contact
- Title
- Courtney Balliro, BS RN CDE
- Organization
- MGH
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Russell, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 21, 2016
Study Start
April 1, 2017
Primary Completion
June 1, 2017
Study Completion
December 28, 2017
Last Updated
July 30, 2018
Results First Posted
July 30, 2018
Record last verified: 2018-07