SMA visits for Type 1 Diabetes

Children's National Hospital, Washington, United States
SMA visitsN/ARecruitingLed by Shideh Majidi, MDResearch Sponsored by Children's National Research Institute

Study Summary

This trial will assess if shared medical appointments help underserved youth with poorly controlled type 1 diabetes in terms of glycemic control, self-management skills, and health related quality of life.

Eligible Conditions
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You identify as Black or Hispanic/Latino.
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You have been diagnosed with type 1 diabetes and have been taking insulin injections for at least a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of SMA sessions attended, as assessed by tracking study visit attendance.
Perceived benefit of the SMA intervention content, as measured by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level)
Perceived satisfaction of SMA intervention as assessed by user satisfaction surveys summary statistics (mean and standard deviation as well as percent answering a specific Likert level), and semi-structured interviews.
+3 more
Secondary outcome measures
CGM Benefits and Burdens scale
Diabetes Self-Management Profile (DSMP) survey
Problem Areas in Diabetes (PAID) scale
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SMA visit intervention armExperimental Treatment1 Intervention
SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver

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Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
198 Previous Clinical Trials
206,407 Total Patients Enrolled
American Diabetes AssociationOTHER
130 Previous Clinical Trials
98,058 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
130 Previous Clinical Trials
29,528 Total Patients Enrolled
Shideh Majidi, MDPrincipal Investigator
Children's National Research Institute

Media Library

SMA Visits Clinical Trial Eligibility Overview. Trial Name: NCT05431686 — N/A
Type 1 Diabetes Research Study Groups: SMA visit intervention arm
Type 1 Diabetes Clinical Trial 2023: SMA Visits Highlights & Side Effects. Trial Name: NCT05431686 — N/A
SMA Visits 2023 Treatment Timeline for Medical Study. Trial Name: NCT05431686 — N/A

Frequently Asked Questions

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

Are there any vacancies in this medical experiment for participants?

"The information posted on the clinicaltrials.gov website demonstrates that this study is presently recruiting participants, with its initial posting occurring on February 16th 2022 and last update taking place in late August of the same year."

Answered by AI

What is the participant enrollment cap for this clinical investigation?

"Indeed, the clinicaltrials.gov website confirms that recruitment for this medical trial is still ongoing; commencing on February 16th 2022 and most recently updated on August 26th 2022. 20 individuals are needed from one single site to take part in the study."

Answered by AI

What is the intention of this experiment?

"DexCom, Inc., the trial sponsor, has stated that their primary measured outcome will be Participant satisfaction of SMA intervention as assessed by user surveys and semi-structured interviews over a 12 month period. Secondary outcomes include: Continuous Glucose Monitor Time within 70-180 mg/dL range; Episodes of Diabetic Ketoacidosis since last study visit; and CGMs Coefficient of Variation across the SMA Intervention & Follow Up Periods."

Answered by AI
~10 spots leftby Jul 2025