Trial Outcomes & Findings for CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D) (NCT NCT03263494)
NCT ID: NCT03263494
Last Updated: 2026-07-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-09
Participant Flow
Participant milestones
| Measure |
Continuous Glucose Monitor (CGM) Group
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
79
|
|
Overall Study
COMPLETED
|
74
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
Baseline characteristics by cohort
| Measure |
Continuous Glucose Monitor (CGM) Group
n=74 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=79 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 3 • n=20 Participants
|
18 years
STANDARD_DEVIATION 3 • n=20 Participants
|
17 years
STANDARD_DEVIATION 3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
48 Participants
n=20 Participants
|
47 Participants
n=20 Participants
|
95 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
3 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Insulin Pump
|
36 Participants
n=20 Participants
|
47 Participants
n=20 Participants
|
83 Participants
n=40 Participants
|
|
Screening HbA1c
|
9.1 percent
STANDARD_DEVIATION 1.0 • n=20 Participants
|
9.1 percent
STANDARD_DEVIATION 1.0 • n=20 Participants
|
9.1 percent
STANDARD_DEVIATION 1.0 • n=40 Participants
|
|
Randomized HbA1c
|
8.9 percent
STANDARD_DEVIATION 1.0 • n=20 Participants
|
8.9 percent
STANDARD_DEVIATION 1.0 • n=20 Participants
|
8.9 percent
STANDARD_DEVIATION 1.0 • n=40 Participants
|
|
Detectable c-peptide
|
41 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
|
C-peptide >0.2 nmol/L
|
13 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Change in HbA1c From Baseline to 26 Weeks Adjusted for Baseline
|
-0.4 percent
Standard Deviation 1.0
|
0.1 percent
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With HbA1c <7.0%
|
8 percent
|
6 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With HbA1c <7.5%
|
18 percent
|
11 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With Relative Reduction ≥ 10%
|
28 percent
|
8 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With Absolute Reduction ≥ 0.5%
|
44 percent
|
21 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With Absolute Reduction ≥ 1%
|
25 percent
|
6 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=71 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
% With Absolute Reduction ≥ 0.5% or HbA1c < 7.0%
|
27 percent
|
11 percent
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM % Time in Range 70-180 mg/dl
|
43 percent
Standard Deviation 15
|
35 percent
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM Mean Glucose
|
199 mg/dL
Standard Deviation 36
|
217 mg/dL
Standard Deviation 35
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM Glucose Variability Measured by Coefficient of Variation
|
39 percent
Standard Deviation 6
|
42 percent
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM % Time > 180 mg/dl
|
57 percent
Interval 41.0 to 66.0
|
61 percent
Interval 51.0 to 72.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM % Time > 300 mg/dl
|
11 percent
Interval 5.0 to 19.0
|
20 percent
Interval 12.0 to 26.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM % Time < 54 mg/dl
|
0.7 percent
Interval 0.2 to 1.4
|
1.3 percent
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM % Time < 70 mg/dl
|
2.2 percent
Interval 1.0 to 5.0
|
3.2 percent
Interval 1.9 to 6.2
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=68 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Rate of CGM Measured Hypoglycemic Episodes (Using <54 mg/dL)
|
1.4 event per week
Interval 0.4 to 2.6
|
1.7 event per week
Interval 1.0 to 3.1
|
SECONDARY outcome
Timeframe: 6 monthsQuestionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
CGM Self Efficacy Questionnaire Score
|
84 score on a scale
Interval 74.0 to 98.0
|
83 score on a scale
Interval 76.0 to 96.0
|
SECONDARY outcome
Timeframe: 6 monthsSurvey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Problem Areas in Diabetes (PAID) Questionnaire Score
|
20 score on a scale
Interval 7.0 to 44.0
|
20 score on a scale
Interval 7.0 to 37.0
|
SECONDARY outcome
Timeframe: 6 monthsSurvey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Glucose Monitoring Satisfaction Questionnaire Score
|
3.9 score on a scale
Interval 3.5 to 4.5
|
3.7 score on a scale
Interval 3.2 to 4.0
|
SECONDARY outcome
Timeframe: 6 monthsSurvey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Hypoglycemia Confidence Questionnaire Score
|
3.7 score on a scale
Interval 3.0 to 4.0
|
3.7 score on a scale
Interval 3.1 to 4.0
|
SECONDARY outcome
Timeframe: 6 monthsSurvey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=71 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=72 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Diabetes Technology Attitudes Questionnaire Score
|
25 score on a scale
Interval 21.0 to 25.0
|
23 score on a scale
Interval 20.0 to 25.0
|
SECONDARY outcome
Timeframe: 6 monthsSurvey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM) Group
n=66 Participants
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=70 Participants
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
|
4.0 score on a scale
Interval 3.0 to 7.0
|
4.0 score on a scale
Interval 3.0 to 6.0
|
Adverse Events
Continuous Glucose Monitor (CGM) Group
Serious events: 9 serious events
Other events: 3 other events
Deaths: 0 deaths
Blood Glucose Monitor (BGM) Group
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Glucose Monitor (CGM) Group
n=74 participants at risk
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=79 participants at risk
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
4.1%
3/74 • Number of events 3 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
2.5%
2/79 • Number of events 3 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
4.1%
3/74 • Number of events 3 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
1.3%
1/79 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
General disorders
Appendicitis
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
General disorders
Fainting
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/74 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
1.3%
1/79 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/74 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
1.3%
1/79 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
General disorders
Syncope
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
Other adverse events
| Measure |
Continuous Glucose Monitor (CGM) Group
n=74 participants at risk
Continuous Glucose Monitor (CGM): Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
|
Blood Glucose Monitor (BGM) Group
n=79 participants at risk
Blood Glucose Monitor (BGM): Participants randomized to the BGM Group will use blood glucose meter without continuous glucose monitor
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
Endocrine disorders
Ketosis
|
0.00%
0/74 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
5.1%
4/79 • Number of events 4 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
General disorders
Lightheadedness
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/74 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
1.3%
1/79 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
|
General disorders
Vomiting
|
1.4%
1/74 • Number of events 1 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
0.00%
0/79 • 6 months
Severe hypoglycemia was defined as an event that required assistance from another person to administer carbohydrate, glucagon, or other resuscitative actions. DKA was defined as an episode when the participant had ketosis that necessitated treatment in a health care facility.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place