Primary outcomeMean· From t=0 to study stop after 2 weeks
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
| Group | Value (mg/dl/min) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 1015 | 883.24 |
| Placebo | 4375.68 | 3058.77 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataClosed-Loop Glucagon Administration For Hypoglycemia Treatment
NCTNCT02181127 (opens ClinicalTrials.gov in a new tab)Other id2013P001663/MGH
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 31 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Nov 2014
- Primary completion
- Jun 2015
- Completion
- Apr 2017
- First posted
- 3 Jul 2014 (estimated)
- Last update posted
- 10 Jan 2019
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes \> 21 years old.
Interventions
- Glucagon-only Bionic PancreasDevice
Arms2
Active comparator
Glucagon-only Bionic Pancreas (active)
Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.
Placebo comparator
Glucagon-only Bionic Pancreas (placebo)
Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.
Primary outcomes1
Outcomes the sponsor listed as primary.
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Time frame · From t=0 to study stop after 2 weeks
Secondary outcomes(20)
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Time frame · 2 weeks
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Time frame · From t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Time frame · from t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Time frame · from t=0 to study stop after 2 weeks
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl
Time frame · from t=0 to stud stop after 2 weeks
Count of Subjects With Mean CGMG < 154mg/dl
Time frame · from t=0 to study stop after 2 weeks
Mean CGMG During Exercise
Time frame · 2 weeks
Registry description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
Time frame · 2 weeks
Registry description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
Time frame · from t=0 to study stop after 2 weeks
Registry description
Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements.
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Time frame · from t=0 to study stop after 2 weeks
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
Time frame · 2 weeks
Registry description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
Time frame · 2 weeks
Registry description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Number of All BG Values Less Than 70 mg/dl
Time frame · from t=0 to study stop after 2 weeks
Number of Study Days With Mean BG < 154 mg/dl
Time frame · 2 weeks
Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl
Time frame · 2 weeks
Registry description
Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.
Mean BG During Exercise
Time frame · 2 weeks
Registry description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Time frame · 2 weeks
Registry description
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Number of Carbohydrate Interventions for Hypoglycemia
Time frame · from t=0 to study stop after 2 weeks
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Time frame · from t=0 to study stop after 2 weeks
Insulin Total Daily Dose
Time frame · from t=0 to study stop after 2 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 2 weeks
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 3.92 | 2.42 |
Secondary outcomeMean· From t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
| Group | Value (number of episodes) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 1.73 | 1.39 |
| Placebo | 5.0 | 3.07 |
Secondary outcomeMean· from t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
| Group | Value (number of episodes) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 4.14 | 2.23 |
| Placebo | 8.86 | 4.57 |
Secondary outcomeMean· from t=0 to study stop after 2 weeks
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
| Group | Value (number of episodes) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 8.95 | 5.55 |
| Placebo | 12.68 | 5.54 |
Secondary outcomeMean· from t=0 to stud stop after 2 weeks
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Glucagon-only Bionic Pancreas | 3.11 | 2.02 |
| Placebo | 8.73 | 5.10 |
Secondary outcomeCount of participants· from t=0 to study stop after 2 weeks
Count of Subjects With Mean CGMG < 154mg/dl
| Group | Value (Participants) |
|---|---|
| Glucagon-only Bionic Pancreas | 13 |
| Placebo | 11 |
Secondary outcome· 2 weeks
Mean CGMG During Exercise
| Group | Value |
|---|---|
| Glucagon-only Bionic Pancreas | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Glucagon-only Bionic PancreasSubjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day). Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor. | – | 0 / 22 | 0 / 22 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Age 21 years or older with type 1 diabetes for at least one year.
* Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
* Self-reported frequency of documented hypoglycemia (BG \< 60 mg/dl) of at least 2 times per week
* Partial hypoglycemic unawareness (inconsistent symptoms with BG \< 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with BG \< 50 mg/dl)
Exclusion Criteria:
* Unable to provide informed consent.
* Unable to comply with study procedures.
* Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
* Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
* History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes
* End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
* Any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis.
* Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or orthopnea).
* Acute illness or exacerbation of chronic illness at the time of the study.
* Seizure disorder or history of hypoglycemic seizure in the last 1 year
* History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
* Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year).
* Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
* Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
* Unwilling or unable to completely avoid acetaminophen during the study period.
* Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
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