Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01083433
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 68
• Location: 1
• Arms: 3
• Duration (Months): 17
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Behavioral: Diabetes related psychological counseling and education; Device: Continuous Glucose Monitor	N/A

Detailed Description

Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Diabetes Care Patients will attend diabetes clinic as usual, once every 3 months.
Experimental: 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.	Behavioral: 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.; Other Names: Diabetes Education Diabetes Psychological Counseling
Experimental: 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.	Behavioral: 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.; Other Names: Diabetes Education Diabetes Psychological Counseling ; Device: 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.; Other Names: Medtronic Minimed iPro

Outcome Measures

Primary Outcome Measures

1. Glycemic Control [Baseline and visit 4]

   Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.

Secondary Outcome Measures

1. Insulin Dose Changes [Baseline and visit 4]

   Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.

2. Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) [Total from baseline to visit 4]

   CGM 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.

3. Adherence to Prescribed Diabetes Regimen [Baseline and visit 4]

   Diabetes 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).

4. Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor [Visit 4]

   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.

5. Diabetes Knowledge [Baseline and month 4]

   The 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division

• Most recent HbA1c >= 8.5%

• Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM

• Patients and families must be willing to come to diabetes clinic once a month for 4 months

Exclusion Criteria:

• Inability to understand and/or speak the English language

• Pregnancy

• Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHCMC	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Sarah A MacLeish, D.O., UHCMC Division of Pediatric Endocrinology
• Principal Investigator: Rebecca A Hazen, Ph.D., UHCMC Division of Behavioral Pediatrics
• Principal Investigator: Leona Cuttler, M.D, UHCMC Division of Pediatric Endocrinology
• Principal Investigator: Rose Gubitosi-Klug, M.D, Ph.D., UHCMC Division of Pediatric Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006 Dec;29(12):2730-2.
• Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.
• El-Osta A, Brasacchio D, Yao D, Pocai A, Jones PL, Roeder RG, Cooper ME, Brownlee M. Transient high glucose causes persistent epigenetic changes and altered gene expression during subsequent normoglycemia. J Exp Med. 2008 Sep 29;205(10):2409-17. doi: 10.1084/jem.20081188. Epub 2008 Sep 22. Erratum in: J Exp Med. 2008 Oct 27;205(11):2683.
• Hirsch IB. Glycemic variability: it's not just about A1C anymore! Diabetes Technol Ther. 2005 Oct;7(5):780-3. Review.
• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
• Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100.
• Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.
• Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7.
• Schaepelynck-Bélicar P, Vague P, Simonin G, Lassmann-Vague V. Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS). Diabetes Metab. 2003 Dec;29(6):608-12.
• Weber C, Schnell O. The assessment of glycemic variability and its impact on diabetes-related complications: an overview. Diabetes Technol Ther. 2009 Oct;11(10):623-33. doi: 10.1089/dia.2009.0043. Review.

• Responsible Party: Sarah A. MacLeish, Physician, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT01083433
• Other Study ID Numbers: RBCDM-01; MH018830
• First Posted: Mar 9, 2010
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Sarah A. MacLeish, Physician, University Hospitals Cleveland Medical Center: Continuous Glucose Monitor; Adherence; Adolescents; Diabetes Education
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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.
Period Title: Overall Study
STARTED	22	23	23
COMPLETED	20	17	18
NOT COMPLETED	2	6	5

Baseline Characteristics

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM	Total
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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 of all reporting groups
Overall Participants	22	23	23	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.4 (2.6)	14.9 (2.6)	14.6 (2.2)	14.6 (2.4)
Sex: Female, Male (Count of Participants)
Female	14 63.6%	13 56.5%	15 65.2%	42 61.8%
Male	8 36.4%	10 43.5%	8 34.8%	26 38.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	6 27.3%	5 21.7%	6 26.1%	17 25%
White	14 63.6%	15 65.2%	16 69.6%	45 66.2%
More than one race	2 9.1%	3 13%	1 4.3%	6 8.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
HbA1c (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	11.0 (2.2)	9.9 (1.3)	10.0 (1.4)	10.3 (1.7)

Outcome Measures

1. Primary Outcome

Title	Glycemic Control
Description	Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Time Frame	Baseline and visit 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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.
Measure Participants	20	17	18
VISIT 4	10.8 (2.2)	9.43 (1.1)	9.4 (0.9)
BASELINE	11.0 (2.1)	9.93 (1.3)	10.0 (1.4)

2. Secondary Outcome

Title	Insulin Dose Changes
Description	Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
Time Frame	Baseline and visit 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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.
Measure Participants	20	17	18
VISIT 4	1.02 (0.3)	1.03 (0.3)	1.10 (0.3)
BASELINE	0.98 (0.3)	1.09 (0.4)	1.0 (0.3)

3. Secondary Outcome

Title	Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
Description	CGM 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.
Time Frame	Total from baseline to visit 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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: Same as Intensive diabetes clinic group. 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.
Measure Participants	22	23	23
Baseline	3.3 (3.3)	3.7 (3.3)	3.8 (3.8)
Visit 4	2.9 (2.0)	4.4 (3.8)	4.0 (5.3)

4. Secondary Outcome

Title	Adherence to Prescribed Diabetes Regimen
Description	Diabetes 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).
Time Frame	Baseline and visit 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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.
Measure Participants	20	17	18
VISIT 4	51 (12.4)	58.0 (8.7)	54.9 (8.9)
BASELINE	47.3 (10.6)	50.2 (11.2)	50.9 (9.8)

5. Secondary Outcome

Title	Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Description	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.
Time Frame	Visit 4

Outcome Measure Data

Analysis Population Description

Some parents did not fill out the survey.

Arm/Group Title	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	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.	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: Same as intensive diabetes clinic group. 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.
Measure Participants	17	18
Overall Patient Satisfaction	6.3 (0.8)	5.5 (1.4)
Overall Parent Satisfaction	6.1 (1.1)	6.6 (0.6)

6. Secondary Outcome

Title	Diabetes Knowledge
Description	The 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.
Time Frame	Baseline and month 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Diabetes Care	Intensive Diabetes Clinic	Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.	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.	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: same as description for intensive diabetes clinic group. 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.
Measure Participants	20	17	18
Parents baseline knowledge	33 (3.3)	33 (2.0)	31 (3.9)
Parents visit 4	33 (2.1)	33 (2.3)	33 (2.4)
Patients baseline	27 (5.9)	28 (7.7)	26 (5.8)
Patients visit 4 knowledge	29 (5.4)	29 (9.1)	29 (4.7)

Adverse Events

Arm/Group Title	Standard Diabetes Care		Intensive Diabetes Clinic		Intensive Diabetes Clinic Plus CGM
Arm/Group Description	Patients will attend diabetes clinic as usual, once every 3 months.		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.		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.
All Cause Mortality
	Standard Diabetes Care		Intensive Diabetes Clinic		Intensive Diabetes Clinic Plus CGM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Standard Diabetes Care		Intensive Diabetes Clinic		Intensive Diabetes Clinic Plus CGM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/22 (18.2%)		1/23 (4.3%)		2/23 (8.7%)
Endocrine disorders
Diabetic Ketoacidosis	4/22 (18.2%)	5	1/23 (4.3%)	1	2/23 (8.7%)	2
Other (Not Including Serious) Adverse Events
	Standard Diabetes Care		Intensive Diabetes Clinic		Intensive Diabetes Clinic Plus CGM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		0/23 (0%)		0/23 (0%)
Infections and infestations
Continuous Glucose Monitor Site Infection	1/22 (4.5%)	1	0/23 (0%)	0	0/23 (0%)	0

Limitations/Caveats

High rate of attrition and lack of outcome data in patients lost to follow-up. Lack of CGM alone group

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.