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Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

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ClinicalTrials.gov Identifier: NCT02411578
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : October 23, 2017
Last Update Posted : November 27, 2017
Sponsor:
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
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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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
Arm/Group Title G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs Glucose Tabs, Then G-Pen Mini Total
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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
Hide 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)
1.Primary Outcome
Title Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
Hide Description [Not Specified]
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Limited to events with starting BG of 50-69 mg/dL
Arm/Group Title G-Pen Mini™ (Glucagon Injection) Glucose Tabs
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide Description Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period
Time Frame 3 weeks
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide Description Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time Frame 3 weeks
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide Description Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time Frame 3 weeks
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide Description Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period
Time Frame 3 weeks
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

  1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
  2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
  3. 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

  1. BG is >=70, no treatment
  2. 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:

  1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
  2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

15 min later, 2nd BG check, 2nd treatment

  1. BG is 60-69 mg/dl, no treatment
  2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
  3. 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

  1. BG is >=70 mg/dl, no treatment
  2. 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%
Show Statistical Analysis 1 Hide 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]
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
Hide 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%)    
Show Serious Adverse Events Hide 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%)    
Show Other (Not Including Serious) Adverse Events Hide 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.
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
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02411578     History of Changes
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: November 27, 2017