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

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ClinicalTrials.gov Identifier: NCT01083433
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah A. MacLeish, University Hospitals Cleveland Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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 Name: Medtronic Minimed iPro




Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083433


Locations
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United States, Ohio
UHCMC
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
National Institute of Mental Health (NIMH)
Investigators
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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
Publications:

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Responsible Party: Sarah A. MacLeish, Physician, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01083433    
Other Study ID Numbers: RBCDM-01
MH018830 ( Other Grant/Funding Number: TRN503976 )
First Posted: March 9, 2010    Key Record Dates
Results First Posted: January 13, 2022
Last Update Posted: January 13, 2022
Last Verified: January 2022
Keywords provided by Sarah A. MacLeish, University Hospitals Cleveland Medical Center:
Continuous Glucose Monitor
Adherence
Adolescents
Diabetes Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases