Trial Outcomes & Findings for Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control (NCT NCT00945659)
NCT ID: NCT00945659
Last Updated: 2018-09-10
Results Overview
Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Baseline, 3, 6, 9 months
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
Standard Care
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
37
|
|
Overall Study
Baseline
|
39
|
40
|
37
|
|
Overall Study
3-Months
|
38
|
39
|
35
|
|
Overall Study
6-Months
|
31
|
29
|
25
|
|
Overall Study
9-Months
|
32
|
20
|
20
|
|
Overall Study
12-Months
|
32
|
20
|
20
|
|
Overall Study
COMPLETED
|
32
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
20
|
17
|
Reasons for withdrawal
| Measure |
Standard Care
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
20
|
17
|
Baseline Characteristics
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
Baseline characteristics by cohort
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in this group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.61 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
13.62 years
STANDARD_DEVIATION 1.82 • n=7 Participants
|
13.46 years
STANDARD_DEVIATION 1.98 • n=5 Participants
|
13.56 years
STANDARD_DEVIATION 1.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Glycated Hemoglobin Level (%)
|
8.84 Percentage of hemoglobin
STANDARD_DEVIATION 0.95 • n=5 Participants
|
9.03 Percentage of hemoglobin
STANDARD_DEVIATION 1.07 • n=7 Participants
|
9.24 Percentage of hemoglobin
STANDARD_DEVIATION 0.83 • n=5 Participants
|
9.03 Percentage of hemoglobin
STANDARD_DEVIATION 0.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, 9 monthsGlycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Glycated Hemoglobin (HbA1c)
Baseline
|
8.84 percentage of hemoglobin molecules
Standard Deviation 0.95
|
9.03 percentage of hemoglobin molecules
Standard Deviation 1.07
|
9.24 percentage of hemoglobin molecules
Standard Deviation 0.83
|
|
Glycated Hemoglobin (HbA1c)
3-Months
|
9.14 percentage of hemoglobin molecules
Standard Deviation 1.38
|
9.06 percentage of hemoglobin molecules
Standard Deviation 1.10
|
8.96 percentage of hemoglobin molecules
Standard Deviation 0.84
|
|
Glycated Hemoglobin (HbA1c)
6-Months
|
8.95 percentage of hemoglobin molecules
Standard Deviation 1.14
|
9.35 percentage of hemoglobin molecules
Standard Deviation 1.30
|
9.09 percentage of hemoglobin molecules
Standard Deviation 1.71
|
|
Glycated Hemoglobin (HbA1c)
9-Months
|
8.96 percentage of hemoglobin molecules
Standard Deviation 1.04
|
9.51 percentage of hemoglobin molecules
Standard Deviation 1.37
|
9.05 percentage of hemoglobin molecules
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline, 3 6, 9 monthsAdolescent's total score on the DTQ-Current items. Range 30-150. Higher scores indicate more favorable satisfaction with and impact of the package of diabetes technology (e.g. pump, meter, CGM, etc.) in use by the patient during the prior 3 months.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Technology Questionnaire-Adolescents
Baseline
|
96.50 Total score
Standard Deviation 18.29
|
101.73 Total score
Standard Deviation 23.26
|
105.16 Total score
Standard Deviation 27.89
|
|
Diabetes Technology Questionnaire-Adolescents
3-Months
|
102.24 Total score
Standard Deviation 24.44
|
92.50 Total score
Standard Deviation 20.28
|
105.95 Total score
Standard Deviation 27.7
|
|
Diabetes Technology Questionnaire-Adolescents
6-Months
|
109.32 Total score
Standard Deviation 19.57
|
107.51 Total score
Standard Deviation 21.65
|
113.19 Total score
Standard Deviation 24.41
|
|
Diabetes Technology Questionnaire-Adolescents
9-Months
|
112.62 Total score
Standard Deviation 23.69
|
103.00 Total score
Standard Deviation 21.95
|
103.93 Total score
Standard Deviation 27.47
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParents' ratings of impact and satisfaction with the diabetes devices currently in use (e.g. pump, meter, CGM etc.) Score range from 30-150. Higher score signify greater satisfaction and impact.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
Baseline
|
90.06 Total scores
Standard Deviation 17.39
|
91.68 Total scores
Standard Deviation 21.34
|
86.87 Total scores
Standard Deviation 27.01
|
|
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
3-Months
|
90.48 Total scores
Standard Deviation 25.03
|
93.78 Total scores
Standard Deviation 21.35
|
95.92 Total scores
Standard Deviation 26.76
|
|
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
6-Months
|
93.21 Total scores
Standard Deviation 25.82
|
94.70 Total scores
Standard Deviation 19.25
|
96.27 Total scores
Standard Deviation 29.64
|
|
Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items
9-Months
|
104.65 Total scores
Standard Deviation 21.61
|
96.79 Total scores
Standard Deviation 18.15
|
98.53 Total scores
Standard Deviation 23.31
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsAdolescent report of communication with parents about blood glucose monitoring and results. Range 8-24. Higher scores indicate more negative communication about BG results.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Blood Glucose Monitoring Communication Questionnaire-Adolescent
Baseline
|
14.24 units on a scale
Standard Deviation 2.84
|
14.46 units on a scale
Standard Deviation 3.04
|
14.29 units on a scale
Standard Deviation 3.5
|
|
Blood Glucose Monitoring Communication Questionnaire-Adolescent
3-Months
|
14.46 units on a scale
Standard Deviation 2.80
|
14.43 units on a scale
Standard Deviation 3.72
|
13.54 units on a scale
Standard Deviation 4.21
|
|
Blood Glucose Monitoring Communication Questionnaire-Adolescent
6-Months
|
13.76 units on a scale
Standard Deviation 3.88
|
14.57 units on a scale
Standard Deviation 4.36
|
13.16 units on a scale
Standard Deviation 4.27
|
|
Blood Glucose Monitoring Communication Questionnaire-Adolescent
9-months
|
14.25 units on a scale
Standard Deviation 3.76
|
14.03 units on a scale
Standard Deviation 4.49
|
14.47 units on a scale
Standard Deviation 4.35
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParents perspectives of communication with adolescent around blood glucose monitoring and results. Score range 8-24. Higher scores signify more negative communication about BG results.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Blood Glucose Monitoring Communication Questionnaire-Parents
Baseline
|
14.08 units on a scale
Standard Deviation 2.83
|
14.59 units on a scale
Standard Deviation 2.87
|
14.29 units on a scale
Standard Deviation 3.50
|
|
Blood Glucose Monitoring Communication Questionnaire-Parents
3-Months
|
14.46 units on a scale
Standard Deviation 3.05
|
15.13 units on a scale
Standard Deviation 3.29
|
12.84 units on a scale
Standard Deviation 3.36
|
|
Blood Glucose Monitoring Communication Questionnaire-Parents
6-Months
|
15.16 units on a scale
Standard Deviation 3.14
|
15.41 units on a scale
Standard Deviation 3.43
|
12.72 units on a scale
Standard Deviation 3.92
|
|
Blood Glucose Monitoring Communication Questionnaire-Parents
9-Months
|
14.46 units on a scale
Standard Deviation 3.39
|
14.36 units on a scale
Standard Deviation 1.95
|
13.69 units on a scale
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsAdolescent ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more frequent family conflict around diabetes.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Family Conflict Scale-Adolescent
Baseline
|
27.72 units on a scale
Standard Deviation 7.25
|
27.54 units on a scale
Standard Deviation 7.92
|
27.59 units on a scale
Standard Deviation 8.37
|
|
Diabetes Family Conflict Scale-Adolescent
3-Months
|
27.41 units on a scale
Standard Deviation 7.22
|
29.70 units on a scale
Standard Deviation 9.57
|
25.26 units on a scale
Standard Deviation 8.16
|
|
Diabetes Family Conflict Scale-Adolescent
6-Months
|
27.07 units on a scale
Standard Deviation 9.31
|
28.73 units on a scale
Standard Deviation 8.48
|
24.35 units on a scale
Standard Deviation 7.69
|
|
Diabetes Family Conflict Scale-Adolescent
9-Months
|
26.68 units on a scale
Standard Deviation 9.31
|
27.29 units on a scale
Standard Deviation 6.56
|
25.06 units on a scale
Standard Deviation 9.09
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParents' ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more family conflict around diabetes.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Family Conflict Scale-Parent
9-Months
|
26.68 units on a scale
Standard Deviation 5.38
|
29.43 units on a scale
Standard Deviation 6.85
|
24.18 units on a scale
Standard Deviation 3.19
|
|
Diabetes Family Conflict Scale-Parent
Baseline
|
28.76 units on a scale
Standard Deviation 7.27
|
27.76 units on a scale
Standard Deviation 5.12
|
27.75 units on a scale
Standard Deviation 6.06
|
|
Diabetes Family Conflict Scale-Parent
3-Months
|
29.36 units on a scale
Standard Deviation 8.48
|
30.29 units on a scale
Standard Deviation 7.82
|
24.85 units on a scale
Standard Deviation 5.13
|
|
Diabetes Family Conflict Scale-Parent
6-Months
|
30.62 units on a scale
Standard Deviation 8.68
|
29.05 units on a scale
Standard Deviation 8.44
|
24.85 units on a scale
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: Baserline, 3, 6, 9 monthsAdolescent's self-ratings of their degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate greater adolescent responsibility for diabetes care.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Family Responsibility Questionnaire-Adolescent
Baseline
|
31.53 units on a scale
Standard Deviation 4.74
|
31.15 units on a scale
Standard Deviation 5.04
|
31.38 units on a scale
Standard Deviation 5.48
|
|
Diabetes Family Responsibility Questionnaire-Adolescent
3-Months
|
31.20 units on a scale
Standard Deviation 5.36
|
31.56 units on a scale
Standard Deviation 4.15
|
30.48 units on a scale
Standard Deviation 5.02
|
|
Diabetes Family Responsibility Questionnaire-Adolescent
6-Months
|
29.85 units on a scale
Standard Deviation 4.88
|
29.96 units on a scale
Standard Deviation 4.15
|
28.71 units on a scale
Standard Deviation 5.53
|
|
Diabetes Family Responsibility Questionnaire-Adolescent
9-Months
|
29.65 units on a scale
Standard Deviation 4.72
|
30.25 units on a scale
Standard Deviation 4.16
|
29.56 units on a scale
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParent ratings of adolescent's degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate great adolescent responsibility for diabetes care tasks.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Family Responsibility Questionnaire-Parent
Baseline
|
34.44 units on a scale
Standard Deviation 4.05
|
35.19 units on a scale
Standard Deviation 5.22
|
33.97 units on a scale
Standard Deviation 5.03
|
|
Diabetes Family Responsibility Questionnaire-Parent
3-Months
|
34.22 units on a scale
Standard Deviation 5.31
|
34.23 units on a scale
Standard Deviation 6.32
|
33.62 units on a scale
Standard Deviation 4.24
|
|
Diabetes Family Responsibility Questionnaire-Parent
6-Months
|
32.50 units on a scale
Standard Deviation 4.19
|
34.35 units on a scale
Standard Deviation 6.47
|
32.30 units on a scale
Standard Deviation 5.19
|
|
Diabetes Family Responsibility Questionnaire-Parent
9-Months
|
32.00 units on a scale
Standard Deviation 4.01
|
35.10 units on a scale
Standard Deviation 5.15
|
33.28 units on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsAdolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Self Management Profile-Adolescent
Baseline
|
57.05 units on a scale
Standard Deviation 14.71
|
60.25 units on a scale
Standard Deviation 13.68
|
59.38 units on a scale
Standard Deviation 12.79
|
|
Diabetes Self Management Profile-Adolescent
3-Months
|
56.82 units on a scale
Standard Deviation 13.88
|
58.73 units on a scale
Standard Deviation 14.19
|
57.79 units on a scale
Standard Deviation 13.47
|
|
Diabetes Self Management Profile-Adolescent
6-Months
|
59.36 units on a scale
Standard Deviation 14.03
|
61.14 units on a scale
Standard Deviation 13.22
|
59.07 units on a scale
Standard Deviation 13.29
|
|
Diabetes Self Management Profile-Adolescent
9-Months
|
55.43 units on a scale
Standard Deviation 14.49
|
58.74 units on a scale
Standard Deviation 13.74
|
58.13 units on a scale
Standard Deviation 14.17
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParent report of adolescent's diabetes self-management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Diabetes Self Management Profile-Parent
Baseline
|
52.76 units on a scale
Standard Deviation 13.81
|
55.45 units on a scale
Standard Deviation 14.06
|
55.94 units on a scale
Standard Deviation 13.37
|
|
Diabetes Self Management Profile-Parent
3-Months
|
54.15 units on a scale
Standard Deviation 13.49
|
58.18 units on a scale
Standard Deviation 14.51
|
59.07 units on a scale
Standard Deviation 12.84
|
|
Diabetes Self Management Profile-Parent
6-Months
|
51.93 units on a scale
Standard Deviation 14.17
|
59.26 units on a scale
Standard Deviation 14.37
|
60.19 units on a scale
Standard Deviation 14.28
|
|
Diabetes Self Management Profile-Parent
9-Months
|
54.38 units on a scale
Standard Deviation 13.65
|
57.16 units on a scale
Standard Deviation 13.58
|
58.73 units on a scale
Standard Deviation 14.11
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsAdolescent worry and behavior related to apprehension of low BG episodes. Score range 24-72. Higher scores indicate greater fear and avoidance of hypoglycemia
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Hypoglycemia Fear Survey-Adolescent
Baseline
|
36.94 units on a scale
Standard Deviation 11.69
|
35.8 units on a scale
Standard Deviation 12.46
|
35.39 units on a scale
Standard Deviation 12.55
|
|
Hypoglycemia Fear Survey-Adolescent
3-Months
|
35.95 units on a scale
Standard Deviation 12.86
|
37.15 units on a scale
Standard Deviation 15.34
|
31.00 units on a scale
Standard Deviation 12.79
|
|
Hypoglycemia Fear Survey-Adolescent
6-Months
|
34.01 units on a scale
Standard Deviation 12.98
|
35.30 units on a scale
Standard Deviation 11.55
|
32.19 units on a scale
Standard Deviation 16.12
|
|
Hypoglycemia Fear Survey-Adolescent
9-Months
|
27.91 units on a scale
Standard Deviation 9.31
|
38.00 units on a scale
Standard Deviation 15.38
|
35.24 units on a scale
Standard Deviation 14.52
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 monthsParental worry and behavior related to apprehension of low BG events. Score range 24-72. Higher scores indicate greater parental fear and avoidance of hypoglycemia.
Outcome measures
| Measure |
Standard Care
n=38 Participants
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Standard Care: Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
|
Continuous Glucose Sensor
n=39 Participants
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Continuous Glucose Sensor: Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
|
CGS + Behavior Therapy
n=35 Participants
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
CGS + Behavior Therapy: Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
|
|---|---|---|---|
|
Hypoglycemia Fear Survey-Parent
9-Months
|
38.48 units on a scale
Standard Deviation 11.62
|
39.87 units on a scale
Standard Deviation 7.48
|
40.67 units on a scale
Standard Deviation 11.24
|
|
Hypoglycemia Fear Survey-Parent
Baseline
|
43.31 units on a scale
Standard Deviation 15.2
|
43.5 units on a scale
Standard Deviation 11.52
|
44.09 units on a scale
Standard Deviation 13.85
|
|
Hypoglycemia Fear Survey-Parent
3-Months
|
40.07 units on a scale
Standard Deviation 12.00
|
41.56 units on a scale
Standard Deviation 10.72
|
39.79 units on a scale
Standard Deviation 9.49
|
|
Hypoglycemia Fear Survey-Parent
6-Months
|
45.59 units on a scale
Standard Deviation 12.70
|
43.14 units on a scale
Standard Deviation 9.49
|
41.76 units on a scale
Standard Deviation 16.71
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Glucose Sensor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CGS + Behavior Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tim Wysocki, PhD
Nemours Foundation: Dept. of Biomedical Research
Phone: 904-697-3483
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place