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The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02660242
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
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: Single (Participant);   Primary Purpose: Prevention
Condition Diabetes Mellitus, Type 1
Interventions Drug: G-Pen Mini™ (glucagon injection)
Other: Glucose Tabs
Other: Basal Insulin Reduction
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MIni-dose Glucagon Crossover Trial
Hide Arm/Group Description Each participant will undergo four aerobic exercise sessions (in random order) of a) a Control Trial: Fasted exercise, no basal insulin reduction; b) Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate five minutes before exercise, for the duration of the exercise); c) Strategy 2: Fasted exercise, no basal adjustment + pre-exercise and mid-exercise glucose tabs (buccal route-40 grams in total); d) Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc). Each period includes 0-165 minutes in the lab and the participant continues to wear a continuous glucose monitor during the afternoon, overnight, and through noon the following day.
Period Title: Control
Started 16
Completed 16
Not Completed 0
Period Title: Basal Insulin Reduction
Started 16
Completed 16
Not Completed 0
Period Title: Glucose Tabs
Started 16 [1]
Completed 15
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
[1]
16 participants were randomized but only 15 completed all 4 periods.
Period Title: Glucagon Injection
Started 16 [1]
Completed 15
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
[1]
16 participants were randomized but only 15 completed all 4 periods.
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes all patients who completed the crossover trial.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
30
(25 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
2
  13.3%
Not Hispanic or Latino
12
  80.0%
Unknown or Not Reported
1
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Type 1 Diabetes Duration, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
22
(14 to 31)
HbA1c  
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 15 participants
6.8
(6.5 to 7.6)
Body Mass Index (BMI)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants
24
(23 to 27)
VO2Max  
Median (Inter-Quartile Range)
Unit of measure:  mL/kg/min
Number Analyzed 15 participants
42
(35 to 51)
1.Primary Outcome
Title Glycemic Response During Exercise and Early Recovery
Hide Description Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
Time Frame 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Plasma Glucose Concentration (End of Exercise) 86  (30) 85  (25) 174  (59) 161  (39)
Plasma Glucose Concentration (End Early Recovery) 90  (34) 92  (34) 222  (66) 163  (49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose <70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery [prior to the meal]), the nadir glucose value was carried forward through the end of early recovery.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.
2.Secondary Outcome
Title Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery
Hide Description Comparison of occurrence of hypoglycemia (<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Time Frame 0 to 75 minutes following exercise initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
6
  40.0%
5
  33.3%
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for subject effect, exercise session, and baseline blood glucose
3.Secondary Outcome
Title Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery
Hide Description Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Time Frame 0 to 75 minutes following exercise initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5
  33.3%
1
   6.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for subject effect, exercise session, and baseline blood glucose
4.Secondary Outcome
Title Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose
Hide Description Comparison of nadir glucose from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data.
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% five minutes before the start of exercise.
Dextrose tabs orally (20 grams) five minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
45
(39 to 60)
44
(40 to 56)
49
(40 to 55)
51
(40 to 53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
5.Secondary Outcome
Title CGM Metrics During Late Recovery - Peak Glucose
Hide Description Comparison of peak glucose from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data.
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
241
(216 to 279)
239
(222 to 299)
267
(211 to 331)
269
(235 to 281)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
6.Secondary Outcome
Title CGM Metrics During Late Recovery - Mean Glucose
Hide Description Comparison of mean glucose from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data.
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
129
(114 to 144)
139
(127 to 149)
130
(117 to 148)
147
(126 to 161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
7.Secondary Outcome
Title CGM Metrics During Late Recovery - Coefficient of Variation
Hide Description Comparison of the coefficient of variation from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Median (Inter-Quartile Range)
Unit of Measure: percentage
32
(29 to 42)
35
(33 to 40)
36
(32 to 42)
33
(31 to 35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
8.Secondary Outcome
Title CGM Metrics During Late Recovery - Time < 54 mg/dL
Hide Description Comparison of percentage of time < 54 mg/dL from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: percentage
3  (3) 3  (3) 3  (1) 2  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
9.Secondary Outcome
Title CGM Metrics During Late Recovery - Time < 70 mg/dL
Hide Description Comparison of percentage of time < 70 mg/dL from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: percentage
10  (9) 8  (6) 8  (6) 6  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
10.Secondary Outcome
Title CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)
Hide Description Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: percentage
73  (12) 71  (10) 69  (20) 67  (15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
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 Accounted for correlation due to cross-over design and adjusted for exercise session
11.Secondary Outcome
Title CGM Metrics During Late Recovery - Time > 180 mg/dL
Hide Description Comparison of percentage of time > 180 mg/dL from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: percentage
16  (13) 21  (12) 23  (20) 26  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
12.Secondary Outcome
Title CGM Metrics During Late Recovery - Time > 250 mg/dL
Hide Description Comparison of percentage of time > 250 mg/dL from CGM between the exercise strategies.
Time Frame 90 min after the standard meal until 1200 noon the day after each exercise session
Hide Outcome Measure Data
Hide Analysis Population Description
Included data were limited to periods with at least 12 hours of CGM data
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description:
No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL).
Basal insulin reduction to 50% 5 minutes before the start of exercise.
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: percentage
1  (2) 4  (9) 9  (17) 5  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Basal Insulin Reduction, Glucose Tabs, G-Pen Mini™ (Glucagon Injection)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mixed Models Analysis
Comments Accounted for correlation due to cross-over design and adjusted for exercise session
Time Frame Adverse Events (AE) were collected 12 hours prior to each exercise session, during each exercise session, and during the day after each exercise session.
Adverse Event Reporting Description

Hypoglycemia, hyperglycemia, injection-related, and exercise-induced events only reported as AEs when criteria below met.

Hypoglycemia: event required dextrose or glucagon to treat; Hyperglycemia: evaluation or treatment obtained from a health care provider or event involved Diabetic Ketoacidosis; Injection-related events: treatment was given; Exercise-induced events: subject falls or has signs of heart attack, poor perfusion, angina, pathologic arrhythmia, or other condition not expected

 
Arm/Group Title Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Hide Arm/Group Description No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL). Basal insulin reduction to 50% 5 minutes before the start of exercise. Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
All-Cause Mortality
Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Basal Insulin Reduction Glucose Tabs G-Pen Mini™ (Glucagon Injection)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
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
Publications:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02660242     History of Changes
Other Study ID Numbers: T1DX Mini-dose Exercise
First Submitted: January 6, 2016
First Posted: January 21, 2016
Results First Submitted: June 6, 2018
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018