Type 1 Diabetes
Conditions
Keywords
bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, glucagon pump
Brief summary
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
DEVICEGlucagon-only Bionic Pancreas
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
Sponsors
Boston University
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl | From t=0 to study stop after 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemic Episodes With CGMG < 50 mg/dl | From t=0 to study stop after 2 weeks | — |
| Number of Hypoglycemic Episodes With CGMG < 60 mg/dl | from t=0 to study stop after 2 weeks | — |
| Number of Hypoglycemic Episodes With CGMG < 70 mg/dl | 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 | from t=0 to stud stop after 2 weeks | — |
| Count of Subjects With Mean CGMG < 154mg/dl | from t=0 to study stop after 2 weeks | — |
| Mean CGMG During Exercise | 2 weeks | 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 | 2 weeks | 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 | from t=0 to study stop after 2 weeks | 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 | from t=0 to study stop after 2 weeks | — |
| Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime | 2 weeks | 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 | 2 weeks | 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 | from t=0 to study stop after 2 weeks | — |
| Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | 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 | 2 weeks | 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 | 2 weeks | 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 | 2 weeks | Times of exercise were not collected during the study, and therefore this outcome cannot be calculated. |
| Number of Carbohydrate Interventions for Hypoglycemia | from t=0 to study stop after 2 weeks | — |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia | from t=0 to study stop after 2 weeks | — |
| Insulin Total Daily Dose | from t=0 to study stop after 2 weeks | — |
| • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | 2 weeks | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) | 2 weeks | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated |
| Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | 2 weeks | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated |
| Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM) | 2 weeks | Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated |
| Total Glucagon Dosing (mcg/kg/24 Hours) | from t=0 to study stop after 2 weeks | — |
| Episodes of Nausea Per Day on Glucagon vs Placebo | from t=0 to study stop after 2 weeks | — |
| Number of Study Days With Mean BG < 154 mg/dl | 2 weeks | — |
Countries
United States
Participant flow
Pre-assignment details
31 participants were enrolled in the trial, but only 22 participants actually participated. 4 subjects were not eligible to participate. The remaining 5 subjects that did not participate were considered back up or benched subjects who were eligible and willing to participate, but were not required to meet our desired total cohort.
Participants by arm
| Arm | Count |
|---|---|
| Glucagon-only Bionic Pancreas Subjects 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Glucagon-only Bionic Pancreas |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 41.9 years STANDARD_DEVIATION 15.2 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl | 1015 mg/dl/min | Standard Deviation 883.24 |
| Placebo | Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl | 4375.68 mg/dl/min | Standard Deviation 3058.77 |
Secondary
Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime
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.
Time frame: 2 weeks
Population: 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.
Secondary
Count of Subjects With Mean CGMG < 154mg/dl
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glucagon-only Bionic Pancreas | Count of Subjects With Mean CGMG < 154mg/dl | 13 Participants |
| Placebo | Count of Subjects With Mean CGMG < 154mg/dl | 11 Participants |
Secondary
Episodes of Nausea Per Day on Glucagon vs Placebo
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Episodes of Nausea Per Day on Glucagon vs Placebo | 1.1 episodes of nausea per day | Standard Deviation 1.6 |
| Placebo | Episodes of Nausea Per Day on Glucagon vs Placebo | 0.4 episodes of nausea per day | Standard Deviation 0.07 |
Secondary
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
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.
Time frame: 2 weeks
Population: 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.
Secondary
• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time frame: 2 weeks
Population: Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glucagon-only Bionic Pancreas | 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 | CGMG < 70 mg/dl | 3.11 percentage of time | Standard Deviation 2.02 |
| Glucagon-only Bionic Pancreas | 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 | CGMG 70-120 mg/dl | 33.32 percentage of time | Standard Deviation 15.85 |
| Glucagon-only Bionic Pancreas | 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 | CGMG 70-180 mg/dl | 68.91 percentage of time | Standard Deviation 15.39 |
| Glucagon-only Bionic Pancreas | 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 | CGMG > 180 mg/dl | 27.98 percentage of time | Standard Deviation 16.44 |
| Glucagon-only Bionic Pancreas | 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 | CGMG > 250 mg/dl | 9.05 percentage of time | Standard Deviation 8.05 |
| Placebo | 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 | CGMG > 250 mg/dl | 9.83 percentage of time | Standard Deviation 8.14 |
| Placebo | 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 | CGMG < 70 mg/dl | 8.73 percentage of time | Standard Deviation 5.1 |
| Placebo | 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 | CGMG > 180 mg/dl | 29.38 percentage of time | Standard Deviation 15.74 |
| Placebo | 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 | CGMG 70-120 mg/dl | 30.53 percentage of time | Standard Deviation 14.74 |
| Placebo | 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 | CGMG 70-180 mg/dl | 61.89 percentage of time | Standard Deviation 13.79 |
Secondary
Insulin Total Daily Dose
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Insulin Total Daily Dose | 38.7 units per day | Standard Deviation 12.6 |
| Placebo | Insulin Total Daily Dose | 37.0 units per day | Standard Deviation 12 |
Secondary
Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values
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.
Time frame: from t=0 to study stop after 2 weeks
Population: This analysis is not broken down according to randomization, because it is intended to give context to the other CGM reported outcomes by reflecting the accuracy of the CGM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values | 15.20 percent difference | Standard Deviation 14.56 |
Secondary
Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime
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.
Time frame: 2 weeks
Population: 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.
Secondary
Mean BG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time frame: 2 weeks
Population: Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Secondary
Mean CGMG During Exercise
Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Time frame: 2 weeks
Population: Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.
Secondary
Number of All BG Values Less Than 70 mg/dl
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of All BG Values Less Than 70 mg/dl | 1.45 number of values | Standard Deviation 1.99 |
| Placebo | Number of All BG Values Less Than 70 mg/dl | 4.23 number of values | Standard Deviation 3.9 |
Secondary
Number of Carbohydrate Interventions for Hypoglycemia
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Carbohydrate Interventions for Hypoglycemia | 1.25 number of interventions per day | Standard Deviation 0.48 |
| Placebo | Number of Carbohydrate Interventions for Hypoglycemia | 1.89 number of interventions per day | Standard Deviation 0.83 |
Secondary
• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time frame: 2 weeks
Population: Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Secondary
Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time frame: 2 weeks
Population: Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Secondary
Number of Hypoglycemic Episodes With CGMG < 50 mg/dl
Time frame: From t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Hypoglycemic Episodes With CGMG < 50 mg/dl | 1.73 number of episodes | Standard Deviation 1.39 |
| Placebo | Number of Hypoglycemic Episodes With CGMG < 50 mg/dl | 5.0 number of episodes | Standard Deviation 3.07 |
Secondary
Number of Hypoglycemic Episodes With CGMG < 60 mg/dl
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Hypoglycemic Episodes With CGMG < 60 mg/dl | 4.14 number of episodes | Standard Deviation 2.23 |
| Placebo | Number of Hypoglycemic Episodes With CGMG < 60 mg/dl | 8.86 number of episodes | Standard Deviation 4.57 |
Secondary
Number of Hypoglycemic Episodes With CGMG < 70 mg/dl
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Hypoglycemic Episodes With CGMG < 70 mg/dl | 8.95 number of episodes | Standard Deviation 5.55 |
| Placebo | Number of Hypoglycemic Episodes With CGMG < 70 mg/dl | 12.68 number of episodes | Standard Deviation 5.54 |
Secondary
Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements | 0.73 number of events | Standard Deviation 0.98 |
| Placebo | Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements | 2.59 number of events | Standard Deviation 2.59 |
Secondary
Number of Study Days With Mean BG < 154 mg/dl
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Number of Study Days With Mean BG < 154 mg/dl | 4.4 number of days | Standard Deviation 2.2 |
| Placebo | Number of Study Days With Mean BG < 154 mg/dl | 4.2 number of days | Standard Deviation 2.2 |
Secondary
Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl
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.
Time frame: 2 weeks
Population: 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.
Secondary
Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glucagon-only Bionic Pancreas | Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | Glucagon - daytime | 3.92 percentage of time | Standard Deviation 2.42 |
| Glucagon-only Bionic Pancreas | Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | Glucagon - overnight | 1.50 percentage of time | Standard Deviation 2.18 |
| Glucagon-only Bionic Pancreas | Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | Placebo - daytime | 7.94 percentage of time | Standard Deviation 4.62 |
| Glucagon-only Bionic Pancreas | Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime | Placebo - overnight | 10.25 percentage of time | Standard Deviation 7.15 |
Secondary
Total Glucagon Dosing (mcg/kg/24 Hours)
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Total Glucagon Dosing (mcg/kg/24 Hours) | 6.84 mcg/kg/day | Standard Deviation 2.9 |
| Placebo | Total Glucagon Dosing (mcg/kg/24 Hours) | 9.8 mcg/kg/day | Standard Deviation 3.6 |
Secondary
Total Number of Grams of Carbohydrate Taken for Hypoglycemia
Time frame: from t=0 to study stop after 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucagon-only Bionic Pancreas | Total Number of Grams of Carbohydrate Taken for Hypoglycemia | 23.90 grams per day | Standard Deviation 9.52 |
| Placebo | Total Number of Grams of Carbohydrate Taken for Hypoglycemia | 36.29 grams per day | Standard Deviation 22.95 |
Secondary
Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time frame: 2 weeks
Population: Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Secondary
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)
Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated
Time frame: 2 weeks
Population: Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated