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

This study has been withdrawn prior to enrollment.
(No participants met inclusion criteria.)
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00829062
First received: January 22, 2009
Last updated: July 29, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Continuous glucose glucose sensor- physician ordered

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Presenting Evidence Based Practice to an Insurance Provider to Expand Coverage of Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic variability as shown by continuous glucose recording [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Glucose sensor
Children who have assented to wear a 72 hour physician ordered continuous glucose monitor.
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.
Other Names:
  • Glucose sensor
  • Continuous glucose sensor
  • Physician ordered glucose sensor

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829062

Locations
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Amanda G Fridlington, MSN Children's Mercy Hospital and Clinics
  More Information

Publications:
Responsible Party: Amanda G. Fridlington, CPNP, Pediatric Nurse Practitioner- Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00829062     History of Changes
Other Study ID Numbers: 08-11-178E
Study First Received: January 22, 2009
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Type 1 diabetes
Insulin pump
Glycemic variability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014