SMA visits for Type 1 Diabetes Mellitus
Phase-Based Progress Estimates
Effectiveness
Safety
Children's National Hospital, Washington, United States
Type 1 Diabetes Mellitus+2 More
SMA visits - BehavioralEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Type 1 Diabetes Mellitus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 16 Secondary · Reporting Duration: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
12 months
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.
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)
Percentage of eligible participants who agreed to participate as assessed by tracking those who were approached to participate and those who agreed to participate
18 months
Percentage of participants with CGM use, as assessed by tracking CGM use status from enrollment to the end of the study.
Month 18
CGM Benefits and Burdens scale
Diabetes Self-Management Profile (DSMP) survey
Problem Areas in Diabetes (PAID) scale
Self-Efficacy for Diabetes Scale (SED) survey
Type 1 Diabetes and Life (T1DAL) survey
continuous glucose monitor coefficient of variation
continuous glucose monitor mean sensor glucose
continuous glucose monitor time above range (>180 mg/dL)
continuous glucose monitor time below range (<70 mg/dL)
continuous glucose monitor time in range from 70-180 mg/dL
continuous glucose monitor wear time
episodes of diabetic ketoacidosis (DKA)
episodes of severe hypoglycemia
hemoglobin A1c
number of emergency room visits
number of hospital admissions
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
SMA visit intervention arm
1 of 2
Individual visit intervention arm
1 of 2
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: SMA visits · No Placebo Group · N/A
SMA visit intervention arm
Behavioral
Experimental Group · 1 Intervention: SMA visits · Intervention Types: BehavioralIndividual visit intervention arm
Behavioral
Experimental Group · 1 Intervention: standard visits · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Closest Location: Children's National Hospital · Washington, United States
2013First Recorded Clinical Trial
2 TrialsResearching Type 1 Diabetes Mellitus
11 CompletedClinical Trials
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
190 Previous Clinical Trials
199,699 Total Patients Enrolled
9 Trials studying Type 1 Diabetes Mellitus
1,364 Patients Enrolled for Type 1 Diabetes Mellitus
American Diabetes AssociationOTHER
126 Previous Clinical Trials
97,455 Total Patients Enrolled
14 Trials studying Type 1 Diabetes Mellitus
1,496 Patients Enrolled for Type 1 Diabetes Mellitus
DexCom, Inc.Industry Sponsor
121 Previous Clinical Trials
13,095 Total Patients Enrolled
41 Trials studying Type 1 Diabetes Mellitus
2,366 Patients Enrolled for Type 1 Diabetes Mellitus
Shideh Majidi, MDPrincipal InvestigatorChildren's National Research Institute
Eligibility Criteria
Age Any Age · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have been diagnosed with type 1 diabetes mellitus and have been treated with insulin injections for at least 1 year.
You are between the ages of 8 and 12 years.
You are fluent in English.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Hilliard, Marisa E., Wendy Levy, Barbara J. Anderson, Amanda L. Whitehouse, Persis V. Commissariat, Kara R. Harrington, Lori M. Laffel, et al.. 2019. “Benefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes”. Diabetes Technology & Therapeutics. Mary Ann Liebert Inc. doi:10.1089/dia.2019.0142.
- Giani, Elisa, Rebecca Snelgrove, Lisa K. Volkening, and Lori M. Laffel. 2016. “Continuous Glucose Monitoring (CGM) Adherence in Youth with Type 1 Diabetes: Associations with Biomedical and Psychosocial Variables”. Journal of Diabetes Science and Technology. SAGE Publications. doi:10.1177/1932296816676280.
- Jeon, Jouhyun, et al.
- 2022. "Group Visits for High Risk Type 1 Diabetes (T1D)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05431686.
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