An interventional study of Community Health Worker added to diabetes team in Type 1 Diabetes Mellitus, Psychosocial Problem and Compliance, Patient, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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Among 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States — 191 open to participants now, 259 under way, 17 of them phase 3. Diabetes Mellitus, Type 1 · United States.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, this one is the 373rd largest by enrollment of the 1,242 interventional ones that give a count, is one of 74 that started in 2018, is one of 614 with no phase, and was the 844th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →191 of the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 31–75 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Medtronic MiniMed, Inc. · Sites in United States
Ages 2–80
University of Colorado, Denver · Sites in United States
Ages 10–20
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 4 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,458 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 206 · Phase 2 267 · Phase 3 167 · Phase 4 74
First in 1983; this study’s year is marked. 74 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 84 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 40 across the 1,242 interventional studies, 64 across the 203 observational. Of the 1,117 that completed or were terminated, 563 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
398 of 1,458 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 5 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
117 of the studies in Diabetes Mellitus, Type 1 with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT06334133Phase 3vTv TherapeuticsCadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | 2027-04 |
| NCT07056699Phase 3The University of Texas Health Science Center at San AntonioSGLT2i, Pioglitazone, and Ketone Production in T1D | 2027-06-01 |
Add all 117 to your calendar (.ics) → With an account.
Among the 1,458 studies in Diabetes Mellitus, Type 1 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.
Diabetic ketoacidosis accounts for 65% of hospitalizations in pediatric patients with type 1 diabetes, and has a mortality rate between 0.15-0.31%. Children with established type 1 diabetes have an 8% annualized risk of developing diabetic ketoacidosis, and this risk increases during adolescence. In addition, socioeconomic and racial disparities are associated with increased risks of poor glycemic control, hospitalization with diabetic ketoacidosis, and even severe hypoglycemia. All of these complications are associated with preventable harm, and lead to increased utilization of medical resources, both in the short- and long-term. Social determinants of health account for over 75% of health outcomes. Thus, it is not surprising that a disproportionate number of children with poor diabetes control and recurrent hospitalization in diabetic ketoacidosis come from vulnerable underserved populations.
In this study, Investigators will study the effect of integrating a community-based healthcare worker into the healthcare team of children with poorly controlled type 1 diabetes. Community Health Workers (CHW) are highly motivated, community members who do not necessarily have prior medical training, but rather they link with the healthcare team to identify and provide relevant social supports to the family. They receive specific training that focuses on issues relevant to improving health outcomes and adherence, by improving medication access, reducing food insecurity, and improving health literacy. The CHW are able to provide real-time assistance with navigating the healthcare and social services systems, reducing family stress and breaking down community barriers to positive health behavior. The CHW work with the family to develop goals and develop an individualized plan to reach these goals. The role of the CHW can include home visits, phone contacts, meeting with school representatives and accompanying patients to appointments.
At the diabetes center at The Children's Hospital of Philadelphia (CHOP), the Community Health Worker will be assigned for one year to patients with high healthcare utilization and / or poorly controlled type 1 diabetes. The support provided for this year will be tailored to the patient's needs but may include problem solving surrounding issues related to work/education, accessing healthcare/medications, engagement with the healthcare team, transportation, housing or food insecurity. Interactions with patients will be through home visits, telephone encounters, text messaging or email. This will be added to their medical care and will be documented in the patient's medical record.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Over the previous one year, the sum of the following should be > 2: diabetes-related hospitalizations plus emergency department visits plus missed appointments (on separate days) or ≥ 9.5 at the time of enrollment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are assigned a community health worker for one year, in addition to standard diabetes care. They do not receive a community health worker for the second year of the study.
Other: Community Health Worker added to diabetes team
Patients receive standard diabetes care for one year. They receive a community health worker for the second year (as part of a crossover trial).
Other: Community Health Worker added to diabetes team
A Community Health Worker will be added to the diabetes team caring for a child with type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.
Hemoglobin A1c
Improvement in glycemic control, as measured by hemoglobin A1c
Time frame: 2 years
Hospital admissions
Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
Time frame: 2 years
Attended outpatient appointments
Data will be extracted from the medical record of each patient to obtain information on the number of attended outpatient appointments.
Time frame: 2 years
Missed outpatient appointments
Data will be extracted from the medical record of each patient to obtain information on the number of missed outpatient appointments.
Time frame: 2 years
Emergency Department utilization
Data will be extracted from the medical record of each patient to obtain information about the number of Emergency Department (ED) visits.
Time frame: 2 years
Primary caregiver's diabetes self-efficacy
The 17-item, "Parental self efficacy in diabetes scale" will be completed by the primary caregiver using a 5-point Likert rating scale. The questionnaire will provide information to assess glycemic control, and sub analysis of results related to diabetes management, problem solving and teaching. This scale ranges in score from 17 to 85, with higher scores consistent with increased self-efficacy.
Time frame: 2 years
Quality of life (primary care giver)
The primary care giver will complete the 36-item "PedsQL Health related quality of life for parents of children with chronic disease" questionnaire (HCCQ) using a 5-point Likert rating scale to assess how their child's illness has had an impact on their quality of life. This scale ranges in score from 0 to 144, with higher scores consistent with decreased quality of life.
Time frame: 2 years
Plan to share: No
Ran from Apr 2018 to primary completion in Mar 2021, 34 months.
Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 34 months is above that.
Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia →