Trial Outcomes & Findings for Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes (NCT NCT01083433)
NCT ID: NCT01083433
Last Updated: 2022-01-13
Results Overview
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline and visit 4
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Standard Diabetes Care
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a CGM for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
23
|
|
Overall Study
COMPLETED
|
20
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
5
|
Reasons for withdrawal
| Measure |
Standard Diabetes Care
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a CGM for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
3
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes
Baseline characteristics by cohort
| Measure |
Standard Diabetes Care
n=22 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=23 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=23 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
HbA1c
|
11.0 percent
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.9 percent
STANDARD_DEVIATION 1.3 • n=7 Participants
|
10.0 percent
STANDARD_DEVIATION 1.4 • n=5 Participants
|
10.3 percent
STANDARD_DEVIATION 1.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and visit 4Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Outcome measures
| Measure |
Standard Diabetes Care
n=20 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=17 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=18 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Glycemic Control
VISIT 4
|
10.8 percent HbA1c
Standard Deviation 2.2
|
9.43 percent HbA1c
Standard Deviation 1.1
|
9.4 percent HbA1c
Standard Deviation 0.9
|
|
Glycemic Control
BASELINE
|
11.0 percent HbA1c
Standard Deviation 2.1
|
9.93 percent HbA1c
Standard Deviation 1.3
|
10.0 percent HbA1c
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and visit 4Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
Outcome measures
| Measure |
Standard Diabetes Care
n=20 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=17 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=18 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Insulin Dose Changes
VISIT 4
|
1.02 u/kg/day
Standard Deviation 0.3
|
1.03 u/kg/day
Standard Deviation 0.3
|
1.10 u/kg/day
Standard Deviation 0.3
|
|
Insulin Dose Changes
BASELINE
|
0.98 u/kg/day
Standard Deviation 0.3
|
1.09 u/kg/day
Standard Deviation 0.4
|
1.0 u/kg/day
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Total from baseline to visit 4CGM downloads at baseline and visit 4 will be used to tabulate the number of episodes of blood glucoses \< 70 mg/dL. At each visit patients will be asked to recall any episodes of severe hypoglycemia that occurred since the last visit. Data from the continuous glucose monitors will be used to evaluate the percent of time that patients are below 70 mg/dL and the number of glucose excursions below 70 mg/dL. Total number of excursions under 70 mg/dL from baseline to visit 4 will be added together.
Outcome measures
| Measure |
Standard Diabetes Care
n=22 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=23 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=23 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
Baseline
|
3.3 number of hypoglycemic excursions
Standard Deviation 3.3
|
3.7 number of hypoglycemic excursions
Standard Deviation 3.3
|
3.8 number of hypoglycemic excursions
Standard Deviation 3.8
|
|
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
Visit 4
|
2.9 number of hypoglycemic excursions
Standard Deviation 2.0
|
4.4 number of hypoglycemic excursions
Standard Deviation 3.8
|
4.0 number of hypoglycemic excursions
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline and visit 4Diabetes Self Management Profile, given to participant (child) at baseline and visit 4. Minimum score zero, maximum score 88. A higher score indicates better adherence. The DSMP is a 10-15 minute, 25-question, validated, structured interview of adherence with diabetes self-management tasks administered separately to parents and youth. It was verbally administered by one pediatric endocrinologist and one trained research assistant. It assesses self-management of exercise and hypoglycemia (7 questions), carbohydrate counting and insulin dose calculation (6 questions), blood glucose and ketone monitoring (8 questions), and insulin timing and dosing (4 questions).
Outcome measures
| Measure |
Standard Diabetes Care
n=20 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=17 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=18 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Adherence to Prescribed Diabetes Regimen
VISIT 4
|
51 Score on a scale
Standard Deviation 12.4
|
58.0 Score on a scale
Standard Deviation 8.7
|
54.9 Score on a scale
Standard Deviation 8.9
|
|
Adherence to Prescribed Diabetes Regimen
BASELINE
|
47.3 Score on a scale
Standard Deviation 10.6
|
50.2 Score on a scale
Standard Deviation 11.2
|
50.9 Score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Visit 4Population: Some parents did not fill out the survey.
Survey of patient and parent satisfaction in the interventions groups only, satisfaction with the overall study including CGM use and psychological intervention. Satisfaction measured on a 7 point Likert scale, with highest satisfaction at a score of 7 and lowest score 1.
Outcome measures
| Measure |
Standard Diabetes Care
n=17 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=18 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Overall Patient Satisfaction
|
6.3 score on a scale
Standard Deviation 0.8
|
5.5 score on a scale
Standard Deviation 1.4
|
—
|
|
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Overall Parent Satisfaction
|
6.1 score on a scale
Standard Deviation 1.1
|
6.6 score on a scale
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and month 4The Diabetes Knowledge Questionnaire was adapted from Butler et al. It is a written questionnaire, self administered independently to parents and children to assess their knowledge about diabetes management. It includes 37 multiple choice questions assessing basic information about diabetes, how to deal with diabetes-related tasks, and management of hypothetical situations. A total score out of 37 possible points is computed for diabetes knowledge, score can range from 0-37. A higher score indicates higher knowledge.
Outcome measures
| Measure |
Standard Diabetes Care
n=20 Participants
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=17 Participants
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=18 Participants
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Diabetes Knowledge
Patients baseline
|
27 score on a scale
Standard Deviation 5.9
|
28 score on a scale
Standard Deviation 7.7
|
26 score on a scale
Standard Deviation 5.8
|
|
Diabetes Knowledge
Parents baseline knowledge
|
33 score on a scale
Standard Deviation 3.3
|
33 score on a scale
Standard Deviation 2.0
|
31 score on a scale
Standard Deviation 3.9
|
|
Diabetes Knowledge
Parents visit 4
|
33 score on a scale
Standard Deviation 2.1
|
33 score on a scale
Standard Deviation 2.3
|
33 score on a scale
Standard Deviation 2.4
|
|
Diabetes Knowledge
Patients visit 4 knowledge
|
29 score on a scale
Standard Deviation 5.4
|
29 score on a scale
Standard Deviation 9.1
|
29 score on a scale
Standard Deviation 4.7
|
Adverse Events
Standard Diabetes Care
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Intensive Diabetes Clinic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intensive Diabetes Clinic Plus CGM
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Diabetes Care
n=22 participants at risk
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=23 participants at risk
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=23 participants at risk
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Endocrine disorders
Diabetic Ketoacidosis
|
18.2%
4/22 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
Other adverse events
| Measure |
Standard Diabetes Care
n=22 participants at risk
Patients will attend diabetes clinic as usual, once every 3 months.
|
Intensive Diabetes Clinic
n=23 participants at risk
Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
|
Intensive Diabetes Clinic Plus CGM
n=23 participants at risk
Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
|
|---|---|---|---|
|
Infections and infestations
Continuous Glucose Monitor Site Infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
0.00%
0/23
|
Additional Information
Sarah A. MacLeish, DO
Rainbow Babies and Children's Hospital
Phone: 216-844-3661
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place