Trial Outcomes & Findings for Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes (NCT NCT00406133)
NCT ID: NCT00406133
Last Updated: 2017-04-14
Results Overview
The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c \>=7.0% cohort).
COMPLETED
PHASE3
451 participants
Baseline and 26 weeks
2017-04-14
Participant Flow
Participants were recruited from within the patient population of the study clinical centers.
Participants completed a run-in phase wearing a blinded continuous glucose monitoring (CGM) device. Eligibility required that a sensor be worn for six out of seven days prior to randomization, with a minimum of 96 hours of glucose values with at least 24 hours overnight, and home blood glucose monitoring be performed at least three times daily.
Participant milestones
| Measure |
Primary Cohort RT-CGM Group
Participants with baseline A1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
Participants with baseline A1c \>=7.0% who were randomized to standard care
|
Secondary Cohort RT-CGM Group
Participants with baseline A1c \<7.0% who were randomized to CGM use
|
Secondary Cohort Control Group
Participants with baseline A1c \<7.0% who were randomized to standard care
|
|---|---|---|---|---|
|
Phase 1 (First 26 Week Period)
STARTED
|
165
|
157
|
67
|
62
|
|
Phase 1 (First 26 Week Period)
COMPLETED
|
162
|
155
|
67
|
60
|
|
Phase 1 (First 26 Week Period)
NOT COMPLETED
|
3
|
2
|
0
|
2
|
|
Phase 2 (Second 26 Week Period)
STARTED
|
159
|
155
|
67
|
60
|
|
Phase 2 (Second 26 Week Period)
COMPLETED
|
157
|
152
|
67
|
60
|
|
Phase 2 (Second 26 Week Period)
NOT COMPLETED
|
2
|
3
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Primary Cohort RT-CGM Group
n=165 Participants
Participants with baseline A1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline A1c \>=7.0% who were randomized to standard care
|
Secondary Cohort RT-CGM Group
n=67 Participants
Participants with baseline A1c \<7.0% who were randomized to CGM use
|
Secondary Cohort Control Group
n=62 Participants
Participants with baseline A1c \<7.0% who were randomized to standard care
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
8-14 years
|
56 participants
n=5 Participants
|
58 participants
n=7 Participants
|
18 participants
n=5 Participants
|
11 participants
n=4 Participants
|
143.0 participants
n=21 Participants
|
|
Age, Customized
15-24 years
|
57 participants
n=5 Participants
|
53 participants
n=7 Participants
|
15 participants
n=5 Participants
|
18 participants
n=4 Participants
|
143.0 participants
n=21 Participants
|
|
Age, Customized
>=25 years
|
52 participants
n=5 Participants
|
46 participants
n=7 Participants
|
34 participants
n=5 Participants
|
33 participants
n=4 Participants
|
165.0 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
248 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
150 participants
n=5 Participants
|
146 participants
n=7 Participants
|
63 participants
n=5 Participants
|
58 participants
n=4 Participants
|
417.0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
34.0 participants
n=21 Participants
|
|
College graduate (subject or primary care giver)
College graduate
|
125 participants
n=5 Participants
|
125 participants
n=7 Participants
|
58 participants
n=5 Participants
|
55 participants
n=4 Participants
|
363.0 participants
n=21 Participants
|
|
College graduate (subject or primary care giver)
Other
|
40 participants
n=5 Participants
|
32 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
88.0 participants
n=21 Participants
|
|
Insulin modality
Pump
|
128 participants
n=5 Participants
|
128 participants
n=7 Participants
|
62 participants
n=5 Participants
|
49 participants
n=4 Participants
|
367.0 participants
n=21 Participants
|
|
Insulin modality
Multiple daily injections
|
37 participants
n=5 Participants
|
29 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
84.0 participants
n=21 Participants
|
|
One or more severe hypoglycemic events in last six months
One or more events
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
38.0 participants
n=21 Participants
|
|
One or more severe hypoglycemic events in last six months
No events
|
151 participants
n=5 Participants
|
147 participants
n=7 Participants
|
60 participants
n=5 Participants
|
55 participants
n=4 Participants
|
413.0 participants
n=21 Participants
|
|
Duration of diabetes
8-14 years
|
6.2 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
5.3 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
4.9 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
4.4 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
5.5 years
STANDARD_DEVIATION 3.0 • n=21 Participants
|
|
Duration of diabetes
15-24 years
|
9.5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
|
Duration of diabetes
>=25 years
|
23.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
21.8 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
24.5 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
|
Glycated hemoglobin (HbA1c)
|
7.9 percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.8 percent
STANDARD_DEVIATION 0.7 • n=7 Participants
|
6.4 percent
STANDARD_DEVIATION 0.5 • n=5 Participants
|
6.5 percent
STANDARD_DEVIATION 0.3 • n=4 Participants
|
7.4 percent
STANDARD_DEVIATION 0.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c \>=7.0% cohort).
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years
|
-0.37 Percent
Standard Deviation 0.90
|
-0.22 Percent
Standard Deviation 0.54
|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years
|
-0.18 Percent
Standard Deviation 0.65
|
-0.21 Percent
Standard Deviation 0.61
|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years
|
-0.50 Percent
Standard Deviation 0.56
|
0.02 Percent
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
The primary outcome was the change in the time per day with glucose values \<=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)
|
54 minutes/day
Interval 28.0 to 108.0
|
91 minutes/day
Interval 27.0 to 188.0
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c \>=7.0% cohort
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (>=1 Severe hypoglycemic event)
|
4 subjects with event
|
6 subjects with event
|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (>=1 Severe hypoglycemic event)
|
3 subjects with event
|
5 subjects with event
|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (>=1 Severe hypoglycemic event)
|
5 subjects with event
|
4 subjects with event
|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (>=1 Severe hypo with seizure or coma)
|
0 subjects with event
|
0 subjects with event
|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (>=1 Severe hypo with seizure or coma)
|
1 subjects with event
|
3 subjects with event
|
|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (>=1 Severe hypo with seizure or coma)
|
1 subjects with event
|
1 subjects with event
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (Baseline)
|
646 minutes/day
Standard Deviation 179
|
710 minutes/day
Standard Deviation 187
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (26 Weeks)
|
750 minutes/day
Standard Deviation 215
|
746 minutes/day
Standard Deviation 223
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (Baseline)
|
691 minutes/day
Standard Deviation 208
|
697 minutes/day
Standard Deviation 201
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (26 Weeks)
|
761 minutes/day
Standard Deviation 188
|
761 minutes/day
Standard Deviation 200
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (Baseline)
|
854 minutes/day
Standard Deviation 202
|
811 minutes/day
Standard Deviation 226
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (26 Weeks)
|
986 minutes/day
Standard Deviation 189
|
840 minutes/day
Standard Deviation 165
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (Baseline)
|
745 minutes/day
Standard Deviation 200
|
671 minutes/day
Standard Deviation 206
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
8-14 years (26 Weeks)
|
643 minutes/day
Standard Deviation 231
|
635 minutes/day
Standard Deviation 240
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (Baseline)
|
650 minutes/day
Standard Deviation 227
|
641 minutes/day
Standard Deviation 198
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (26 Weeks)
|
394 minutes/day
Standard Deviation 200
|
519 minutes/day
Standard Deviation 185
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
15-24 years (26 Weeks)
|
591 minutes/day
Standard Deviation 226
|
591 minutes/day
Standard Deviation 203
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
>=25 years (Baseline)
|
497 minutes/day
Standard Deviation 216
|
549 minutes/day
Standard Deviation 248
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
8-14 years (Baseline)
|
343 minutes/day
Standard Deviation 177
|
282 minutes/day
Standard Deviation 151
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
>=25 years (26 Weeks)
|
101 minutes/day
Standard Deviation 116
|
161 minutes/day
Standard Deviation 103
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
8-14 years (26 Weeks)
|
242 minutes/day
Standard Deviation 167
|
268 minutes/day
Standard Deviation 172
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
15-24 years (Baseline)
|
271 minutes/day
Standard Deviation 162
|
265 minutes/day
Standard Deviation 157
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
15-24 years (26 Weeks)
|
215 minutes/day
Standard Deviation 154
|
242 minutes/day
Standard Deviation 187
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
>=25 years (Baseline)
|
149 minutes/day
Standard Deviation 112
|
181 minutes/day
Standard Deviation 150
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL)
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (Baseline)
|
49 minutes/day
Standard Deviation 68
|
59 minutes/day
Standard Deviation 67
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (26 Weeks)
|
47 minutes/day
Standard Deviation 59
|
59 minutes/day
Standard Deviation 60
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (26 Weeks)
|
88 minutes/day
Standard Deviation 88
|
88 minutes/day
Standard Deviation 79
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
>=25 years (26 Weeks)
|
60 minutes/day
Standard Deviation 54
|
81 minutes/day
Standard Deviation 89
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (Baseline)
|
99 minutes/day
Standard Deviation 79
|
102 minutes/day
Standard Deviation 93
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
>=25 years (Baseline)
|
89 minutes/day
Standard Deviation 128
|
80 minutes/day
Standard Deviation 71
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=50 mg/dL)
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (Baseline)
|
17 minutes/day
Standard Deviation 39
|
18 minutes/day
Standard Deviation 34
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (26 Weeks)
|
10 minutes/day
Standard Deviation 21
|
13 minutes/day
Standard Deviation 22
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (Baseline)
|
37 minutes/day
Standard Deviation 49
|
42 minutes/day
Standard Deviation 61
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
>= 25 years (26 Weeks)
|
11 minutes/day
Standard Deviation 19
|
23 minutes/day
Standard Deviation 37
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (26 Weeks)
|
29 minutes/day
Standard Deviation 48
|
31 minutes/day
Standard Deviation 43
|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
>=25 years (Baseline)
|
32 minutes/day
Standard Deviation 86
|
22 minutes/day
Standard Deviation 30
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Glucose variability was assessed by computing the absolute rate of change.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (Baseline)
|
0.84 Mean mg/dl/minute
Standard Deviation 0.18
|
0.83 Mean mg/dl/minute
Standard Deviation 0.17
|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
8-14 years (26 Weeks)
|
0.82 Mean mg/dl/minute
Standard Deviation 0.21
|
0.83 Mean mg/dl/minute
Standard Deviation 0.21
|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (Baseline)
|
0.85 Mean mg/dl/minute
Standard Deviation 0.25
|
0.86 Mean mg/dl/minute
Standard Deviation 0.17
|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
15-24 years (26 Weeks)
|
0.84 Mean mg/dl/minute
Standard Deviation 0.21
|
0.87 Mean mg/dl/minute
Standard Deviation 0.21
|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
>=25 years (Baseline)
|
0.73 Mean mg/dl/minute
Standard Deviation 0.18
|
0.72 Mean mg/dl/minute
Standard Deviation 0.18
|
|
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
>=25 years (26 Weeks)
|
0.68 Mean mg/dl/minute
Standard Deviation 0.15
|
0.74 Mean mg/dl/minute
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).
The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c \<7.0% cohort), as determined by a central laboratory.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)
|
0.02 Percent
Standard Deviation 0.45
|
0.33 Percent
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
|
1063 minutes/day
Interval 948.0 to 1185.0
|
949 minutes/day
Interval 784.0 to 1106.0
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
|
283 minutes/day
Interval 173.0 to 423.0
|
341 minutes/day
Interval 232.0 to 502.0
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort
|
48 minutes/day
Interval 11.0 to 103.0
|
82 minutes/day
Interval 22.0 to 149.0
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=50 mg/dL)
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)
|
4 minutes/day
Interval 0.0 to 15.0
|
8 minutes/day
Interval 0.0 to 55.0
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Glucose variability was assessed by computing the absolute rate of change.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=66 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=60 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)
|
0.66 mg/dl/min
Interval 0.53 to 0.76
|
0.66 mg/dl/min
Interval 0.54 to 0.87
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Participants \>= 18 years of age. Pools participants with baseline HbA1c \<7.0% and \>=7.0%.
Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=120 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=106 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Quality of Life
|
33.3 units on a scale
Standard Deviation 11.5
|
36.0 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Baseline A1c\<7%.
Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Cost-effectiveness of CGM.
|
70904 dollars per QALY
|
49438 dollars per QALY
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Baseline A1c \<7.0%
Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged \<18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
QALW
|
23.23 weeks
Standard Error 0.81
|
21.84 weeks
Standard Error 0.66
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Baseline A1c \< 7.0%
Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09-2042/DC1 (Table 1).
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Total Costs: Direct and Indirect Costs
|
31675 dollars
Standard Error 6292
|
20764 dollars
Standard Error 4351
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A relative decrease in A1c level \>=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
16 participants
|
7 participants
|
|
Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
8 participants
|
5 participants
|
|
Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
>=25 years
|
13 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A relative increase in A1c level by \>=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
5 participants
|
2 participants
|
|
Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
2 participants
|
2 participants
|
|
Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
>=25 years
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A relative decrease A1c level by \>=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
30 participants
|
18 participants
|
|
Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
20 participants
|
19 participants
|
|
Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
>=25 years
|
24 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A relative increase by in A1c level \>=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
12 participants
|
7 participants
|
|
Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
7 participants
|
7 participants
|
|
Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
>=25 years
|
0 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A 26-week A1c level \<7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
15 participants
|
7 participants
|
|
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
8 participants
|
9 participants
|
|
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
>= 25 years
|
17 participants
|
4 participants
|
POST_HOC outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=165 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
8-14 years
|
14 participants
|
6 participants
|
|
26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
15-24 years
|
7 participants
|
7 participants
|
|
26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
>=25 years
|
15 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
|
21 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
|
19 participants
|
31 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 26 weeksPopulation: All analyses were performed according to the intention-to-treat principle.
Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Outcome measures
| Measure |
Primary Cohort CGM Group
n=67 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=62 Participants
Participants with baseline HbA1c \>=7.0% who were randomized to standard care
|
|---|---|---|
|
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)
|
59 participants
|
38 participants
|
Adverse Events
Primary Cohort RT-CGM Group
Primary Cohort Control Group
Secondary Cohort RT-CGM Group
Secondary Cohort Control Group
Serious adverse events
| Measure |
Primary Cohort RT-CGM Group
n=165 participants at risk
Participants with baseline A1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 participants at risk
Participants with baseline A1c \>=7.0% who were randomized to standard care
|
Secondary Cohort RT-CGM Group
n=67 participants at risk
Participants with baseline A1c \<7.0% who were randomized to CGM use
|
Secondary Cohort Control Group
n=62 participants at risk
Participants with baseline A1c \<7.0% who were randomized to standard care
|
|---|---|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
4.2%
7/165 • Number of events 7
|
7.6%
12/157 • Number of events 12
|
10.4%
7/67 • Number of events 7
|
11.3%
7/62 • Number of events 7
|
Other adverse events
| Measure |
Primary Cohort RT-CGM Group
n=165 participants at risk
Participants with baseline A1c \>=7.0% who were randomized to CGM use
|
Primary Cohort Control Group
n=157 participants at risk
Participants with baseline A1c \>=7.0% who were randomized to standard care
|
Secondary Cohort RT-CGM Group
n=67 participants at risk
Participants with baseline A1c \<7.0% who were randomized to CGM use
|
Secondary Cohort Control Group
n=62 participants at risk
Participants with baseline A1c \<7.0% who were randomized to standard care
|
|---|---|---|---|---|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/165
|
0.64%
1/157 • Number of events 1
|
0.00%
0/67
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Cellulitis related to sensor use
|
1.2%
2/165 • Number of events 2
|
0.00%
0/157
|
0.00%
0/67
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Dizziness during blood draw
|
0.00%
0/165
|
0.64%
1/157 • Number of events 1
|
0.00%
0/67
|
0.00%
0/62
|
|
Psychiatric disorders
Anxiety and depression
|
0.61%
1/165 • Number of events 1
|
0.00%
0/157
|
0.00%
0/67
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Kidney laceration
|
0.00%
0/165
|
0.64%
1/157 • Number of events 1
|
0.00%
0/67
|
0.00%
0/62
|
|
General disorders
Seizure not caused by hypoglycemia
|
0.61%
1/165 • Number of events 1
|
0.00%
0/157
|
0.00%
0/67
|
0.00%
0/62
|
Additional Information
Roy W. Beck, M.D., Ph.D., Director
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60