NCT05066893

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2024

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

September 23, 2021

Last Update Submit

September 23, 2021

Conditions

Type 1 DiabetesChildren, Only

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    3 months

Study Arms (2)

standard of care

ACTIVE COMPARATOR

standard of care will be given as per usual care

Other: telehealth visits

intensive monitoring

EXPERIMENTAL

intensive monitoring every week will be given to participants

Other: telehealth visits

Interventions

telehealth visitsOTHER

intensive visits with doctor

intensive monitoringstandard of care

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Not able to attend telehealth visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medstar Pediatrics

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

November 5, 2020

Primary Completion

November 5, 2023

Study Completion

November 5, 2024

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)