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Insulin Delivery Technology

AHCL pump for Type 1 Diabetes

N/A
Waitlist Available
Led By Stuart A Chalew, M.D.
Research Sponsored by Children's Hospital New Orleans, LA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Typical clinical presentation at diagnosis
Prior documentation of one or more anti-pancreatic antibodies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in hba1c will be assessed from baseline to the hba1c at 6 months (end of study)
Awards & highlights

Study Summary

This trial is testing whether an intervention using an advanced insulin delivery pump + home video management conferencing with a study CDE nurse coordinator can sustainably improve blood sugar levels in African American patients with type 1 diabetes to levels comparable to European American patients, without increasing hypoglycemia.

Eligible Conditions
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in hba1c will be assessed from baseline to the hba1c at 6 months (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in hba1c will be assessed from baseline to the hba1c at 6 months (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Secondary outcome measures
Blood Glucose
Other outcome measures
DSMP-SR Change from Baseline to 6 months (End of Study)
PedsQL-Diabetes Module Change from Baseline to 6 months (study end)
Time in Glucose Range Change From Baseline to 6 months (End of study)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Video Conferencing+Current Insulin DeliveryExperimental Treatment1 Intervention
Patients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator
Group II: AHCL pump+Video ConferencingExperimental Treatment2 Interventions
Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing
Group III: AHCL pump without Video ConferencingExperimental Treatment1 Intervention
Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support
Group IV: Current Diabetes Management ContinuedActive Control1 Intervention
Continued Insulin Delivery Method and Current Clinic Care of Diabetes

Find a Location

Who is running the clinical trial?

Children's Hospital New Orleans, LALead Sponsor
1 Previous Clinical Trials
810 Total Patients Enrolled
Stuart A Chalew, M.D.Principal InvestigatorChildren's Hospital of New Orleans/ LSUHSC Dept of Pediatrics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical investigation include geriatric individuals?

"This research is looking for volunteers aged 10-17 years old."

Answered by AI

Does this medical trial still have spots open to partake in it?

"As per information on clinicaltrials.gov, this medical trial is no longer recruiting participants. This research had initially been posted in November 2020 and was last updated late October of the same year. Although this study has closed its doors to new candidates, there are currently 371 other investigations that are actively enrolling patients."

Answered by AI

Is it possible for me to partake in this medical research?

"This clinical trial is accepting 120 applicants between the ages of 10 and 17, who suffer from type 1 diabetes mellitus."

Answered by AI
Recent research and studies
~28 spots leftby Mar 2025