Recruiting

Observational Study

Sponsor:

Georgetown University

Code:

NCT05066893

Conditions

Type 1 Diabetes

Children, Only

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

telehealth visits

Study Details

Brief summary:

An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.

Conditions

Type 1 Diabetes

Children, Only

Study ID

NCT05066893

Start date

Nov 5, 2020

Status verified date

Sep, 2021

Completion date

Nov 5, 2024

Anticipated

Primary completion date

Nov 5, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 11-18 years old
2. HbA1c > 8.5%
3. Duration of type 1 diabetes >1 year
4. Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app.

Exclusion Criteria:

Not able to attend telehealth visits

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: standard of care

standard of care will be given as per usual care

experimental: intensive monitoring

intensive monitoring every week will be given to participants

Interventions

telehealth visits

intensive visits with doctor

Primary outcome measure

  • Change in HbA1c [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Medstar Pediatrics

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Principal Investigator:

Evgenia Gourgari, MD

More Information

Sponsor

Georgetown University

Last update posted

Oct 4, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2021-10-04.