Expanding Coverage of Continuous Subcutaneous Insulin Infusion in Pediatric Patients With Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Presenting Evidence Based Practice to an Insurance Provider to Expand Coverage of Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients With Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00829062
• Other study ID #: 08-11-178E
• Status: Withdrawn
• Phase: N/A
• First received: January 22, 2009
• Last updated: July 29, 2010
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to present evidence based literature and clinical data to the medical directors at Missouri Medicaid to help modify the existing policy regarding insulin pump therapy in pediatric patients with diabetes.

Description:

Results from the Diabetes Control and Complications Trial (DCCT) showed that more aggressive and intensive management of diabetes leads to a reduction in the incidence of diabetes related complications in adolescents and adults. Therefore, early initiation of intensive insulin regimens that have been proven to normalize blood sugars as much as possible need to be initiated in youth with type 1 diabetes mellitus (T1DM) to improve outcomes in adulthood. However, despite this understanding, there remains no consensus for how to best manage insulin delivery in children diagnosed with T1DM.

Intensive insulin treatment of diabetes typically entails one of two therapies: MDI (multiple daily injections) or CSII also know as insulin pump therapy. MDI requires several insulin injections per day to achieve near normal glycemic control which can also lead to a subsequent increased risk of severe hypoglycemia. The insulin pump allows the user to program in various basal insulin rates, as low as 0.025 units/hr, throughout the day and night to better match one's physiologic insulin secretion, and eliminates the need for insulin injections throughout the day.

Management of T1DM in the pediatric setting presents several challenges for the patient, caregivers, and health care providers. Children and adolescents tend to have wide fluctuations in their blood glucose levels due to varying amounts of physical activity from day to day. Additionally, infants, toddlers, and school age children have eating habits that are very unpredictable and often eat small quantities making it quite difficult to accurately administer small doses of insulin through an insulin syringe or pen device. Finally, there is increasing evidence to support that infants and toddlers who experience severe hypoglycemia may have resultant neurologic deficits. Previous research has demonstrated that pediatric patients on insulin pump therapy had better glycemic control when compared to pediatric patients who were managed on MDI alone. Patients on insulin pumps and their parents have reported more flexibility with meals and daily activities, lower hemoglobin A1c levels, decreased variability in blood sugar readings, and fewer episodes of hypoglycemia.

Despite the vast research documenting the benefits of insulin pump therapy, some insurance companies continue to be hesitant in covering CSII in pediatric patients with diabetes. The findings from this study and supporting evidence will be presented to medical directors at Missouri Medicaid to help expand coverage of CSII in pediatric patients with diabetes.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 17 Years

Eligibility

Inclusion Criteria:

• Patients aged 12 months-17 years old diagnosed with Type I Diabetes Mellitus receiving diabetes care at Children's Mercy Hospital

• Patients/families must be able to read and speak English

• Patients will need to have had a minimum of 3 clinic visits over the past year

• Patients who are recipients of Missouri Medicaid that have been denied or are awaiting Medtronic MiniMed insulin pump coverage

• Patients receiving insulin injections

Exclusion Criteria:

• Non Missouri Medicaid patients on insulin injections

• Recipients of Missouri Medicaid who are currently on insulin pump therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Continuous glucose glucose sensor- physician ordered
Charts will be reviewed to identify recipients of Missouri Medicaid who receive daily injections to manage their diabetes. Children who have submitted an application for the Medtronic MiniMed insulin pump will be identified by the PI and Medtronic Diabetes. They will be asked to wear a 72 hour continuous glucose monitor. The children who wear the sensor will be asked to keep a daily logbook of their blood sugars, activities, food intake, and insulin doses during this 72 hour period. The families of the children will be provided with a pre-addressed FedEx envelope for them to return the digital recorder and daily logbooks to the PI. The results of the glucose sensor will be downloaded by the PI. The families will be contacted by the PI with the results and treatment recommendations.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (4)

Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV. Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes. Diabetes Care. 1999 Nov;22(11):1779-84. — View Citation

Ramchandani N, Ten S, Anhalt H, Sinha S, Ching J, Finkelstein A, Maclaren NK. Insulin pump therapy from the time of diagnosis of type 1 diabetes. Diabetes Technol Ther. 2006 Dec;8(6):663-70. — View Citation

Shalitin S, Phillip M. The role of new technologies in treating children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2007 Oct;8 Suppl 6:72-9. Review. — View Citation

Weinzimer SA, Ahern JH, Doyle EA, Vincent MR, Dziura J, Steffen AT, Tamborlane WV. Persistence of benefits of continuous subcutaneous insulin infusion in very young children with type 1 diabetes: a follow-up report. Pediatrics. 2004 Dec;114(6):1601-5. Erratum in: Pediatrics. 2005 Feb;115(2):518. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim of this project is to present evidence based practice to Missouri Medicaid to expand coverage of continuous subcutaneous insulin infusion (CSII) in pediatric patients with diabetes. - Hemoglobin A1C		12 months	No
Secondary	Glycemic variability as shown by continuous glucose recording		3-5 days	No