NCT00829062

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

1.5 years

First QC Date

January 22, 2009

Last Update Submit

July 29, 2010

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesInsulin pumpGlycemic variability

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Glycemic variability as shown by continuous glucose recording

    3-5 days

Study Arms (1)

Glucose sensor

NO INTERVENTION

Children who have assented to wear a 72 hour physician ordered continuous glucose monitor.

Device: Continuous glucose glucose sensor- physician ordered

Interventions

Continuous glucose glucose sensor- physician orderedDEVICE

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.

Also known as: Glucose sensor, Continuous glucose sensor, Physician ordered glucose sensor
Glucose sensor

Eligibility Criteria

Age12 Months - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Related 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. doi: 10.2337/diacare.22.11.1779.

    PMID: 10546007BACKGROUND

  • 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. doi: 10.1089/dia.2006.8.663.

    PMID: 17109598BACKGROUND

  • 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. doi: 10.1111/j.1399-5448.2007.00279.x.

    PMID: 17727388BACKGROUND

  • 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. doi: 10.1542/peds.2004-0092.

    PMID: 15574621BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Amanda G Fridlington, MSN

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations

US(1)