The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

NCT02509065 | Completed Results DMC

• 1 other identifier: 2015P001260
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

bionic pancreas; artificial pancreas; insulin; glucagon; continuous glucose monitor (CGM); insulin pump; outpatient

Outcome Measures

Primary Outcomes (3)

• Mean Continuous Glucose Monitor (CGM) Glucose Values

  Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.

  Days 2 and 3

• Percentage of Time With CGM < 60 mg/dl

  For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation.

  Days 2 and 3

• Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit

  During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes

  Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)

Secondary Outcomes (10)

• Mean CGM Glucose

  Days 1 through 3

• Nausea Severity

  Days 1-3

• Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl

  Days 2-3

• Percentage of Subjects With Mean CGM < 154 mg/dl

  Days 2-3

• Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements

  Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)

Study Arms (9)

Usual Care

ACTIVE COMPARATOR

Comparator week to all closed-loop control, utilizing usual diabetes care and the subject's own insulin pump.

Other: Usual Care

145 mg/dl Set Point - insulin only

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 145 mg/dl and using only an insulin pump.

Device: Bionic Pancreas

130 mg/dl Set Point - insulin only

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl and using only an insulin pump. This arm is for subjects with type 1 diabetes only. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.

Device: Bionic Pancreas

130 mg/dl Set Point - bihormonal

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 130 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.

Device: Bionic Pancreas

115 mg/dl Set Point - bihormonal

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 115 mg/dl using both an insulin and a glucagon pump.

Device: Bionic Pancreas

100 mg/dl Set Point - bihormonal

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 100 mg/dl using both an insulin and a glucagon pump.

Device: Bionic Pancreas

110 mg/dl Set Point - insulin only

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl and using only an insulin pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.

Device: Bionic Pancreas

110 mg/dl Set Point - bihormonal

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 110 mg/dl using both an insulin and a glucagon pump. This arm is double blinded; neither the subject nor the study team know if it is insulin only or bihormonal.

Device: Bionic Pancreas

120 mg/dl Set Point - insulin only

EXPERIMENTAL

Automated blood glucose control via a closed-loop bionic pancreas device targeting a blood glucose level of 120 mg/dl and using only an insulin pump.

Device: Bionic Pancreas

Interventions

Bionic Pancreas DEVICE

Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.

100 mg/dl Set Point - bihormonal; 110 mg/dl Set Point - bihormonal; 110 mg/dl Set Point - insulin only; 115 mg/dl Set Point - bihormonal; 120 mg/dl Set Point - insulin only; 130 mg/dl Set Point - bihormonal; 130 mg/dl Set Point - insulin only; 145 mg/dl Set Point - insulin only

Usual Care OTHER

Participant cares for their diabetes according to their usual practice, with blinded CGM monitoring. No medication will be administered by the study in this intervention.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 Diabetes Subjects: Age ≥ 18 years and have had clinical type 1 diabetes for at least one year, and managed using an insulin pump for ≥ 6 months Type 2 Diabetes subjects: Age ≥ 18 years and have type 2 diabetes managed with rapid acting insulin in an insulin pump, or multiple daily injections including both long acting and short acting insulin
• 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 two infusion sets and one 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)
• Have a mobile phone they are willing to keep with them and answer calls from study staff

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
• 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 besides type 1 diabetes
• 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
• Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Masscahusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Courtney A Balliro
• Organization: Massachusetts General Hospital

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Some of the study arms are double blinded: the 110 mg/dl and 130 mg/dl set point configurations of the bionic pancreas are double blinded, so neither the patient nor the study team know if they are using the bihormonal bionic pancreas or insulin only bionic pancreas
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 27, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 20, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-10

Locations

US (1)