Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

• ClinicalTrials.gov Identifier: NCT02411578
• Recruitment Status: Completed
• First Posted: April 8, 2015
• Results First Posted: October 23, 2017
• Last Update Posted: March 3, 2020
• Sponsor: Jaeb Center for Health Research
• Collaborator: Xeris Pharmaceuticals
• Information provided by (Responsible Party): Jaeb Center for Health Research

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 1
• Interventions: Drug: G-Pen Mini™ (glucagon injection); Other: Glucose Tablets
• Enrollment: 26

Participant Flow

Recruitment Details
Pre-assignment Details	26 consented for Run-in; 1 ineligible after consent; 2 ineligible after Run-in phase; 3 withdrew

Arm/Group Title	G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs	Glucose Tabs, Then G-Pen Mini
Arm/Group Description	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Period Title: Crossover Trial Phase
Started	8	12
Completed	8	11
Not Completed	0	1
Reason Not Completed
Pregnancy	0	1
Period Title: Extension Phase
Started	8	9 [1]
Completed	8	9
Not Completed	0	0
[1] 2 Crossover Trial participants could not continue due to study syringes expiration

Baseline Characteristics

Arm/Group Title		G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs	Glucose Tabs, Then G-Pen Mini	Total
Arm/Group Description		For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Total of all reporting groups
Overall Number of Baseline Participants		6	10	16
Baseline Analysis Population Description		Characteristics of the 16 participants with analyzable hypoglycemic events (1 of 20 participants randomized was dropped due to pregnancy and 3 participants did not have any analyzable hypoglycemic events.)
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants	10 participants	16 participants
		41.5 (9.1)	36.9 (12.2)	38.6 (11.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	10 participants	16 participants
	Female	3 50.0%	9 90.0%	12 75.0%
	Male	3 50.0%	1 10.0%	4 25.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	10 participants	16 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	6 100.0%	10 100.0%	16 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	10 participants	16 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	6 100.0%	10 100.0%	16 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Hemoglobin A1c; Mean (Standard Deviation); Unit of measure: %
	Number Analyzed	6 participants	10 participants	16 participants
		6.9 (0.6)	7.4 (0.9)	7.2 (0.8)
Duration of Type 1 Diabetes; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants	10 participants	16 participants
		24.8 (14.2)	22.5 (15.8)	23.4 (14.8)

Outcome Measures

1. Primary Outcome

Title	Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
Description	[Not Specified]
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

Limited to events with starting BG of 50-69 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	16	16
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	62	56
Count of Units; Unit of Measure: Hypoglycemic Events
	58 93.5%	53 94.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.99
	Comments	Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.
	Method	Mixed Models Analysis
	Comments	[Not Specified]

2. Secondary Outcome

Title	Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level
Description	Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time Frame	60 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study BG meter (BGM) if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	59; (52 to 66)	56; (52 to 60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.34
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

3. Secondary Outcome

Title	CGM Maximum Glucose, Event Level
Description	Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time Frame	60 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	102; (83 to 119)	116; (98 to 143)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

4. Secondary Outcome

Title	CGM Mean Glucose, Event Level
Description	Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time Frame	60 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	79; (69 to 91)	87; (77 to 102)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

5. Secondary Outcome

Title	CGM Time in Range, Event Level
Description	Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time Frame	60 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	62; (42 to 79)	67; (58 to 71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.86
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

6. Secondary Outcome

Title	CGM Time Below 70 mg/dL, Event Level
Description	Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time Frame	60 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	35; (13 to 58)	33; (26 to 42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.95
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

7. Secondary Outcome

Title	CGM Minimum Glucose, Event Level
Description	Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time Frame	120 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	57; (51 to 65)	56; (52 to 60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.78
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

8. Secondary Outcome

Title	CGM Maximum Glucose, Event Level
Description	Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time Frame	120 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	122; (102 to 159)	139; (116 to 161)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.21
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

9. Secondary Outcome

Title	CGM Mean Glucose, Event Level
Description	Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time Frame	120 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	95; (77 to 113)	108; (89 to 119)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.09
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

10. Secondary Outcome

Title	CGM Time in Range, Event Level
Description	Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time Frame	120 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	79; (50 to 88)	79; (69 to 86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.49
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

11. Secondary Outcome

Title	CGM Time Below 70 mg/dL
Description	Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time Frame	120 Minutes

Outcome Measure Data

Analysis Population Description

A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	48	36
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	20; (9 to 40)	19; (13 to 25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.63
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

12. Secondary Outcome

Title	CGM Mean Glucose
Description	Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Limited to participants who had at least 72 hours of CGM data during each period

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Median (Inter-Quartile Range); Unit of Measure: mg/dL
	143; (135 to 169)	149; (136 to 177)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.41
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

13. Secondary Outcome

Title	CGM Time in Range
Description	Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Limited to participants who had at least 72 hours of CGM data during each period

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	71; (60 to 79)	71; (57 to 79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.80
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

14. Secondary Outcome

Title	CGM Time Below 70
Description	Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Limited to participants who had at least 72 hours of CGM data during each period

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Median (Inter-Quartile Range); Unit of Measure: percentage of time
	5; (2 to 7)	4; (2 to 6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.13
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

15. Secondary Outcome

Title	CGM Coefficient of Variation
Description	Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Limited to participants who had at least 72 hours of CGM data during each period

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	15	15
Median (Inter-Quartile Range); Unit of Measure: percentage coefficient of variation
	35; (33 to 40)	36; (35 to 39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.70
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.

16. Post-Hoc Outcome

Title	Clinical Grading - Limited to Events in Primary Analysis
Description	2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	16	16
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	59	56
Count of Units; Unit of Measure: Hypoglycemic Events
	57 96.6%	54 96.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.93
	Comments	Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.
	Method	Mixed Models Analysis
	Comments	[Not Specified]

17. Post-Hoc Outcome

Title	Clinical Grading - Initial and 15-min Treatment Correct
Description	2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct.

4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	16	16
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	69	67
Count of Units; Unit of Measure: Hypoglycemic Events
	66 95.7%	63 94.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.66
	Comments	Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.
	Method	Mixed Models Analysis
	Comments	[Not Specified]

18. Post-Hoc Outcome

Title	Clinical Grading - Initial Treatment Correct
Description	2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements.

8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period.

Arm/Group Title	G-Pen Mini™ (Glucagon Injection)	Glucose Tabs
Arm/Group Description:	For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment; BG is 50-69 mg/dl, treatment is 150 µg of glucagon; BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 150 µg of glucagon; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates; BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment; BG is 60-69 mg/dl, no treatment; BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates; BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment; BG is >=70 mg/dl, no treatment; BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Overall Number of Participants Analyzed	16	16
Overall Number of Units Analyzed; Type of Units Analyzed: Hypoglycemic Events	95	92
Count of Units; Unit of Measure: Hypoglycemic Events
	84 88.4%	88 95.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-Pen Mini™ (Glucagon Injection), Glucose Tabs
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.08
	Comments	Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events were collected through study completion, an average of 12 weeks.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	G-Pen Mini™ (Glucagon Injection)		Glucose Tabs
Arm/Group Description	Participants treat non-severe hypoglycemic events with glucagon.		Participants treat non-severe hypoglycemic events with glucose tabs.
All-Cause Mortality
	G-Pen Mini™ (Glucagon Injection)		Glucose Tabs
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/20 (0.00%)		0/20 (0.00%)
Serious Adverse Events
	G-Pen Mini™ (Glucagon Injection)		Glucose Tabs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0.00%)		0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	G-Pen Mini™ (Glucagon Injection)		Glucose Tabs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10.00%)		1/20 (5.00%)
Pregnancy, puerperium and perinatal conditions
Unintended Pregnancy † 1 [1]	1/20 (5.00%)	1	0/20 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection † 1 [2]	1/20 (5.00%)	1	0/20 (0.00%)	0
Streptococcal Sore Throat † 1 [3]	1/20 (5.00%)	1	1/20 (5.00%)	1
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment; [1] Not related to study drug or procedures. Recovered with Sequelae; [2] Not related to study drug or procedures. Complete Recovery.; [3] Not related to study drug or procedures. Occurred during Extension Phase when participant taking both G-Pen Mini and Glucose Tabs. Complete Recovery.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Stephanie DuBose
• Organization: Jaeb Center for Health Research
• Phone: 813-975-8690
• EMail: t1dstats2@jaeb.org

Publications:

Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes. 2008 Dec;57(12):3169-76. doi: 10.2337/db08-1084. Review.

Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin North Am. 2010 Sep;39(3):641-54. doi: 10.1016/j.ecl.2010.05.003. Review.

Raju B, Arbelaez AM, Breckenridge SM, Cryer PE. Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. J Clin Endocrinol Metab. 2006 Jun;91(6):2087-92. Epub 2006 Feb 21.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8.

Haymond MW, Schreiner B. Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes. Diabetes Care. 2001 Apr;24(4):643-5.

Hartley M, Thomsett MJ, Cotterill AM. Mini-dose glucagon rescue for mild hypoglycaemia in children with type 1 diabetes: the Brisbane experience. J Paediatr Child Health. 2006 Mar;42(3):108-11.

Hasan KS, Kabbani M. Mini-dose glucagon is effective at diabetes camp. J Pediatr. 2004 Jun;144(6):834.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haymond MW, DuBose SN, Rickels MR, Wolpert H, Shah VN, Sherr JL, Weinstock RS, Agarwal S, Verdejo AS, Cummins MJ, Newswanger B, Beck RW; T1D Exchange Mini-dose Glucagon Study Group. Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2994-3001. doi: 10.1210/jc.2017-00591.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT02411578
• Other Study ID Numbers: T1DX Mini-dose Non-Severe
• First Submitted: March 27, 2015
• First Posted: April 8, 2015
• Results First Submitted: August 3, 2017
• Results First Posted: October 23, 2017
• Last Update Posted: March 3, 2020