Group Visits for High Risk Type 1 Diabetes (T1D)

NCT05431686 | Completed Results

• 1 other identifier: Pro00016268
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (6)

• Percentage of Eligible Participants Who Agreed to Participate as Assessed by Tracking Those Who Were Approached to Participate and Those Who Agreed to Participate

  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.

  12 months

• Percentage of Participants With CGM Use, as Assessed by Tracking CGM Use Status From Enrollment to the End of the Study.

  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.

  18 months

• Frequency of SMA Sessions Attended, as Assessed by Tracking Study Visit Attendance.

  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.

  12 months

• Perceived Satisfaction of SMA Intervention as Assessed by Semi-structured Interviews.

  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.

  12 months

• 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)

  Youth and caregivers randomized to the SMA intervention will complete user satisfaction ratings at the end of the SMA intervention to evaluate intervention utility. Investigators will report results of the satisfaction ratings, with the goal of \>80% reporting perceived utility as a measure of acceptability.

  12 months

• 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)

  Youth and caregivers randomized to the SMA intervention will complete user satisfaction ratings at the end of the SMA intervention to evaluate intervention benefit. Investigators will report results of the satisfaction ratings, with the goal of \>80% reporting perceived benefit as a measure of acceptability.

  12 months

Secondary Outcomes (16)

• Percentage of Time in Range (70-180 mg/dl)

  baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

• Continuous Glucose Monitor Time Below Range (<70 mg/dL)

  baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

• Continuous Glucose Monitor Time Above Range (>180 mg/dL)

  baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

• Continuous Glucose Monitor Mean Sensor Glucose

  baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

• Continuous Glucose Monitor Coefficient of Variation

  baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

Study Arms (1)

SMA visit intervention arm

EXPERIMENTAL

SMAs will occur once every 3 months, and consist of 4-6 underserved youth with T1D and their primary diabetes caregiver

Behavioral: SMA visits

Interventions

SMA visits BEHAVIORAL

SMA visit once every 3 months over a 12 month period

SMA visit intervention arm

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 12 years
• Poorly controlled T1D: one A1c value \> 8% in the preceding year
• Fluent in English as the Dexcom technology is currently available only in English
• Participation of the primary diabetes caregiver

You may not qualify if:

• 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

Sponsors & Collaborators

• DexCom, Inc.: collaborator
• Children's National Research Institute: lead
• American Diabetes Association: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (4)

• Giani E, Snelgrove R, Volkening LK, Laffel LM. Continuous Glucose Monitoring (CGM) Adherence in Youth With Type 1 Diabetes: Associations With Biomedical and Psychosocial Variables. J Diabetes Sci Technol. 2017 May;11(3):476-483. doi: 10.1177/1932296816676280. Epub 2016 Nov 1.

  PMID: 27807014 BACKGROUND

• Jeon, Jouhyun, et al.

  BACKGROUND

• Hilliard ME, Levy W, Anderson BJ, Whitehouse AL, Commissariat PV, Harrington KR, Laffel LM, Miller KM, Van Name M, Tamborlane WV, DeSalvo DJ, DiMeglio LA. Benefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes. Diabetes Technol Ther. 2019 Sep;21(9):493-498. doi: 10.1089/dia.2019.0142. Epub 2019 Jul 9.

  PMID: 31287721 BACKGROUND

• Grundman JB, Majidi S, Perkins A, Streisand R, Monaghan M, Marks BE. Applying the use of shared medical appointments (SMAs) to improve continuous glucose monitor (CGM) use, glycemic control, and quality of life in marginalized youth with type 1 diabetes: Study protocol for a pilot prospective cohort study. Contemp Clin Trials Commun. 2023 Jan 16;32:101067. doi: 10.1016/j.conctc.2023.101067. eCollection 2023 Apr.

  PMID: 36698741 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

limited sample size as enrollment was challenging and there was a limited subset of participants who completed the protocol

Results Point of Contact

• Title: Dr. Jody Grundman
• Organization: Children's National Hospital

jgrundman@childrensnational.org

2024762121

Study Officials

• Shideh Majidi, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will include the intervention group participating in the SMA visits (n=20)

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: June 24, 2022
• Study Start: February 16, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)