N/A Completed N=14 Supportive Care

Group Visits for High Risk Type 1 Diabetes (T1D)

Source: ClinicalTrials.gov NCT05431686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcomePrimary: Percentage of Eligible Participants Who Agreed to Participate as Assessed by Tracking Those Who Were Approached to Participate and Those Who Agreed to Participate — 14 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eligible Participants Who Agreed to Participate as Assessed by Tracking Those Who Were Approached to Participate and Those Who Agreed to Participate	14	—
PRIMARY Percentage of Participants With CGM Use, as Assessed by Tracking CGM Use Status From Enrollment to the End of the Study.	87.5	—
PRIMARY Frequency of SMA Sessions Attended, as Assessed by Tracking Study Visit Attendance.	90	—
PRIMARY Perceived Satisfaction of SMA Intervention as Assessed by Semi-structured Interviews.	2	—
PRIMARY Perceived Utility 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)	—	—
PRIMARY 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)	—	—
SECONDARY Percentage of Time in Range (70-180 mg/dl)	27.25; 21.75; 23.67; 29.00; 33.33; 38.00	—
SECONDARY Continuous Glucose Monitor Time Below Range (<70 mg/dL)	2.45; 0.97; 4.00; 2.00; 1.60; 2.50	—
SECONDARY Continuous Glucose Monitor Time Above Range (>180 mg/dL)	78.00; 80.77; 72.33; 69.00; 61.33; 60.00	—
SECONDARY Continuous Glucose Monitor Mean Sensor Glucose	247.75; 259.25; 245.33; 241.50; 239.00; 219.67	—
SECONDARY Continuous Glucose Monitor Coefficient of Variation	41.40; 30.80; 41.47; 42.30; 43.30; 44.85	—
SECONDARY Continuous Glucose Monitor Wear Time	63.40; 67.33; 64.33; 89.50; 74.00; 71.13	—
SECONDARY Episodes of Diabetic Ketoacidosis (DKA)	0; 0; 0; 0; 0; 0	—
SECONDARY Episodes of Severe Hypoglycemia	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Emergency Room Visits	0; 0.5; 0; 0; 0; 0	—
SECONDARY Number of Hospital Admissions	0; 0; 0; 0; 0; 0	—
SECONDARY Hemoglobin A1c	11.28; 10.60; 10.47; 9.35; 9.67; 10.70	—
SECONDARY Type 1 Diabetes and Life (T1DAL) Survey	67.95; 74.70; 66.63; 72.32; 68.45; 76.49	—
SECONDARY Diabetes Self-Management Profile (DSMP) Survey	47.97; 42.44; 37.65; 65.41; 33.58; 38.95	—
SECONDARY Self-Efficacy for Diabetes Scale (SED) Survey	45.84; 70.23; 65.29; 68.41; 53.77; 65.91	—
SECONDARY Problem Areas in Diabetes (PAID) Scale	50.0; 59.69; 50.66; 64.06; 27.28; 67.81	—
SECONDARY CGM Benefits and Burdens Scale	133.12; 81.25; 96.25; 68.13; 108.12; 46.88	—

Eligibility Criteria

Inclusion Criteria

Patients clinically diagnosed with T1D managed with insulin injections for at least 1 year
Non-Hispanic Black or Latinx ethnicity
Public healthcare insurance
Male or female ages ≥ 8 and 8% in the preceding year
Fluent in English as the Dexcom technology is currently available only in English
Participation of the primary diabetes caregiver

Exclusion Criteria

Use of insulin pump therapy for diabetes management at time of enrollment
Major illnesses other than T1D
Significant cognitive limitations and major psychiatric disorders in the child or
Concurrent use of any non-insulin diabetes medication to control blood glucose levels.
Concurrent participation in any other clinical studies during study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05431686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.