8 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Eligible Participants Who Agreed to Participate as Assessed by Tracking Those Who Were Approached to Participate and Those Who Agreed to ParticipatePrimary· 12 months
Investigators will track all patients who screened eligible to participate in the study, as well as those who that were contacted to gauge interest in participating. Investigators will track the percent of people who agreed to participate from those that were approached, with the goal of \>60% of those reached/eligible to participate agreeing to enroll as a measure of feasibility.
Group
Value
95% CI
SMA Visit Intervention Arm
14
Percentage of Participants With CGM Use, as Assessed by Tracking CGM Use Status From Enrollment to the End of the Study.Primary· 18 months
For those who agree to enroll, investigators will classify participant's CGM use status at time of enrollment as either current CGM users, never CGM users, or those with CGM attrition. At the completion of the study, CGM use status will be assessed, with the goal of \>80% current CGM users among study participants as a measure of feasibility.
Group
Value
95% CI
SMA Visit Intervention Arm
87.5
80.1 – 92.7
Frequency of SMA Sessions Attended, as Assessed by Tracking Study Visit Attendance.Primary· 12 months
For those who agree to enroll, investigators will document if participants attended or were absent from scheduled study visits. At the completion of the study, attendance will be assessed, with the goal of \>80% sessions attended among study participants as a measure of feasibility.
Group
Value
95% CI
SMA Visit Intervention Arm
90
80 – 100
Perceived Satisfaction of SMA Intervention as Assessed by Semi-structured Interviews.Primary· 12 months
Thematic analysis of qualitative data will be conducted by two team members who independently review interview transcripts to generate initial codes. Initial codes will be discussed by the group to generate a list of second-cycle codes and each team member will then apply coding framework to all transcripts before identifying dominant themes. ATLAS.ti software will be used to organize and analyze qualitative data.
Group
Value
95% CI
SMA Visit Intervention Arm
2
Percentage of Time in Range (70-180 mg/dl)Secondary· baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
We will look at differences in the percent of time that blood sugar values are in range within subject measures across the SMA intervention and during the follow up period.
We will look at differences in the percent of time that blood sugar values are below range within subject measures across the SMA intervention and during the follow up period.
We will look at differences in the percent of time that blood sugar values are above range within subject measures across the SMA intervention and during the follow up period.
We will look at differences in the coefficient of variation values within subject measures across the SMA intervention and during the follow up period.
We will look at differences in number of episodes of DKA since the last study visit within subject measures across the SMA intervention and during the follow up period.
baseline
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
3 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
6 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
9 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
12 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
15 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
18 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
Episodes of Severe HypoglycemiaSecondary· baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
We will look at differences in number of episodes of severe hypoglycemia since the last study visit within subject measures across the SMA intervention and during the follow up period.
baseline
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
3 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
6 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
9 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
12 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
15 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
18 months
Group
Value
95% CI
SMA Visit Intervention Arm
0
± 0
Sponsor's own description
The investigators propose to conduct a pilot prospective cohort study to assess the impact of shared medical appointments (SMA) visits in underserved youth with poorly controlled type 1 diabetes (T1D). The trial will employ an enrollment visit, SMA visits every 3 months over a 12 month study period, followed by a 6-month observational period to assess feasibility and acceptability of SMA and the impact on glycemic control, self-management skills, and health related quality of life.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's National Research Institute
Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05431686.