Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes - Full Text View

Sponsor:	University Hospital Case Medical Center
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by:	University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT01083433

Purpose

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	Intervention
Type 1 Diabetes Mellitus	Behavioral: Diabetes related psychological counseling and education Device: Continuous Glucose Monitor

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:

Glycemic Control [ Time Frame: Baseline and then every month for four months ] [ Designated as safety issue: Yes ]
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4. Rapid HbA1c using capillary blood will be measured at every visit. Blood glucose meter average will be obtained at every visit. Emergency room visits, hospital admissions, and emergency phone calls for hyperglycemia and ketonuria will be tracked.

Secondary Outcome Measures:

Insulin dose changes [ Time Frame: Baseline and every month for four months ] [ Designated as safety issue: No ]
Insulin doses in units per kilogram per day will be calculated at each visit.
Episodes of Hypoglycemia (blood glucose <70 mg/dL) [ Time Frame: Every month for four months ] [ Designated as safety issue: Yes ]
Blood glucose meter downloads 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.
Glycemic Variability [ Time Frame: Baseline and month 4 ] [ Designated as safety issue: No ]
Glycemic variability will be evaluated from data from continuous glucose monitor downloads.
Adherence to prescribed diabetes regimen [ Time Frame: Baseline and every month for four months ] [ Designated as safety issue: No ]
Adherence will be measured using the Diabetes Self Management Profile, the Self Care Inventory, average number of blood glucose tests the patient completes per day, the amount of time the patient wears the continuous glucose monitor, number of missed insulin injections, insulin usage, and clinic attendance.
Satisfaction with intensive diabetes clinic and usage of the continuous glucose monitor [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Diabetes Knowledge [ Time Frame: Baseline and month 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	May 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083433

Contacts

Contact: Sarah A MacLeish, D.O.

216-844-3661

sarah.macleish2@uhhospitals.org

Locations

United States, Ohio
UHCMC	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sarah A. MacLeish, D.O. 216-844-3661 sarah.macleish2@uhhospitals.org
Principal Investigator: Sarah A MacLeish, D.O.

Sponsors and Collaborators

University Hospital Case 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

More Information

Publications:

[No authors listed] The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86.

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.

Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4.

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. Review.

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. 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. No abstract available.

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.

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. No abstract available.

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.

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. Epub 2008 Sep 8.

Responsible Party:	Sarah A. MacLeish, UHCMC Division of Pediatric Endocrinology
ClinicalTrials.gov Identifier:	NCT01083433 History of Changes
Other Study ID Numbers:	RBCDM-01, MH018830
Study First Received:	March 8, 2010
Last Updated:	May 27, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:

Continuous Glucose Monitor
Adherence
Adolescents
Diabetes Education

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012