- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476788
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
March 20, 2017 updated by: Michael Stalvey, MD, University of Alabama at Birmingham
Fast Track Continuous Subcutaneous Insulin Infusion (CSII) in Children With Newly Diagnosed Type 1 Diabetes Mellitus: An Evaluation of a Novel CSII Device in the Immediate Period Following Diagnosis of Type 1 Diabetes (T1DM)
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device.
The outcomes of interest are the feasibility and potential metabolic benefits of this approach.
We anticipate that the initiation of this CSII device in the immediate post-diagnosis period in this population will result in good glycemic control and greater parental satisfaction when compared to intensive insulin injection therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The incidence of type 1 diabetes (T1DM) is on the rise worldwide, especially in children younger than six years of age.
Glycemic control using multiple daily injection (MDI) therapy can be difficult to achieve and maintain in the very young, especially in the immediate post-diagnosis period.
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device.
The outcomes of interest are the feasibility, safety, and potential metabolic benefits of this approach.
We will recruit 14 pediatric patients, aged one to ten years, from a pool of all children newly diagnosed with T1DM admitted to the Children's Hospital of Alabama to use the pump.General diabetes education and CSII-specific training will take place in a series of outpatient sessions with the PI and study nurse.
Pump therapy will be initiated within two months of diagnosis providing that all requisite education and training has been successfully completed.
Data will be collected for both study group and control group patients for six months via phone calls and monthly clinic visits.
Areas which will be evaluated include glycemic control, residual endogenous insulin secretion, frequency of severe adverse events, parental distress, insulin needs, and physical growth.
While initiating CSII in the immediate post-diagnosis period in this population may be initially time-intensive, it is anticipated that it will ultimately become time-saving because of the greater ease in blood sugar management.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 1 through 10 years of age
- Patients present to the Children's Hospital of Alabama with a new diagnosis of type 1 diabetes
- Patients may be admitted to the inpatient unit
- OR from the ER
- OR or from an outside facility to Children's Hospital
- Or seen in our outpatient clinic for the first time having been diagnosed at an outside facility
- If patients are recruited from the outside facility in our outpatient clinic, the diagnosis must have been made within two weeks of the visit. Twenty patients and twenty control subjects will be recruited over a six-month period.
Exclusion Criteria:
- Patients with diabetes due to other causes (neonatal diabetes, pancreatitis, cystic fibrosis, etc.)
- Patients will younger than 2 years of age
- Patients older than 8 years of age
- Lack any presence of other systemic disease(s), such as neoplastic disease or renal failure.
- Patients must have adequate parental support and stable home environment (e.g. children in foster care or with a history of suspected abuse or neglect would be excluded).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omnipod Device
Patients will be placed on an Omnipod insulin pump
|
Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Glycated Hemoglobin (A1c)
Time Frame: 6.9 months (average)
|
Measure of glycemic control (A1c) over preceding 8 weeks.
Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
|
6.9 months (average)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Reported Adverse Events
Time Frame: 6.9 months (average)
|
adverse events are defined as a change from baseline
|
6.9 months (average)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elaine C Moreland, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
May 18, 2007
First Submitted That Met QC Criteria
May 18, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X060928006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Omnipod Insulin Management System
-
Insulet CorporationCompletedType 2 Diabetes MellitusUnited States
-
Mountain Diabetes and Endocrine CenterCompletedInsulin Resistance | Type 2 DiabetesUnited States
-
Hoffmann-La RocheCompletedDiabetes Mellitus, Type 1Austria, Germany, Poland, United Kingdom
-
Medtrum FranceAxonal-BiostatemNot yet recruitingType 1 DiabetesFrance
-
Insulet CorporationCompletedType 1 DiabetesUnited States
-
Insulet CorporationActive, not recruiting
-
Insulet CorporationRecruitingDiabetes Mellitus, Type 1Belgium, France, United Kingdom
-
Tandem Diabetes Care, Inc.Not yet recruiting
-
Rabin Medical CenterCompleted
-
Emory UniversityJaeb Center for Health Research; Insulet CorporationCompletedDiabetes MellitusUnited States