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Completed

NCT Number: NCT03374462

Type 1 Diabetes Telemedicine

At the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with T1D.

Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic. Specifically:

A) Patients and families choose to participate in telemedicine visits as a supplement to in-person care; B) Patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; C) Patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality.

Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone.

Aim 3. To test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients.

Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ED) visits and diabetes-related hospitalizations.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 1-17 years
  • known diagnosis of T1D
  • >1 prior visit to the UC Davis Pediatric Endocrinology clinic (to avoid enrolling newly diagnosed patients)
  • suboptimal glycemic control, defined as most recent hemoglobin A1C level of >8%
  • access to the internet via a device with video and audio capability (e.g. computer, tablet, mobile phone)
  • ability to connect their home glucose meter to an internet-capable device via Bluetooth or physical cable for the purpose of data uploading.

Exclusion criteria

  • Patients and parents whose primary language is not English
  • Patients who have Western Health Advantage health insurance

Treatment and study plan

Telemedicine Intervention

Behavioral

Home-based telemedicine visits

Primary outcomes

  1. Improvement in A1C Levels

    Time frame: 12-months

    Investigators will compare the mean pre-study and mean post-study A1C levels

Secondary outcomes

  1. Increased visit frequency

    Time frame: 24-months

    Investigators will evaluate if offering telemedicine visits leads to increased visit frequency for these patients during the 12-month study period, when compared to the previous 12-months

  2. Impact on high-cost health care utilization

    Time frame: 24-months

    Investigators will compare the mean number of ED visits and mean number of diabetes-related hospitalizations for patients in the cohort

  3. Feasibility of home-based telemedicine

    Time frame: 12-months

    Investigators will evaluate the feasibility of home-based telemedicine for the patient population by the percent of eligible patients who enroll in the study and the percent of enrolled patients who complete the study

  4. Acceptability of home-based telemedicine

    Time frame: 12-months

    Investigators will evaluate the acceptability of home-based telemedicine for the patient population by the percent of those completing the study who express satisfaction with the telemedicine experience.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Use of Home-Based Telemedicine to Improve Healthcare Utilization and Outcomes in Pediatric Patients With Poorly Controlled Type 1 Diabetes

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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