Clinical trial NCT01083433: Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes
Official title: Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Continuous Glucose Monitor
Adherence
Adolescents
Diabetes Education
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-03-09
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Glycemic Control
timeFrame: Baseline and visit 4
Secondary outcomes:
measure: Insulin Dose Changes
timeFrame: Baseline and visit 4
measure: Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
timeFrame: Total from baseline to visit 4
measure: Adherence to Prescribed Diabetes Regimen
timeFrame: Baseline and visit 4
measure: Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
timeFrame: Visit 4
measure: Diabetes Knowledge
timeFrame: Baseline and month 4
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UHCMC
state: Ohio
Study officials:
affiliation: UHCMC Division of Pediatric Endocrinology
name: Sarah A MacLeish, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: UHCMC Division of Behavioral Pediatrics
name: Rebecca A Hazen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UHCMC Division of Pediatric Endocrinology
name: Leona Cuttler, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: UHCMC Division of Pediatric Endocrinology
name: Rose Gubitosi-Klug, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hirsch IB. Glycemic variability: it's not just about A1C anymore! Diabetes Technol Ther. 2005 Oct;7(5):780-3. doi: 10.1089/dia.2005.7.780. No abstract available.
citation: 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. doi: 10.1177/193229680800200618.
citation: 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. doi: 10.2337/dc06-1134. No abstract available.
citation: Schaepelynck-Belicar 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. doi: 10.1016/s1262-3636(07)70076-9.
citation: 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.