Diabetes Mellitus, Type 1NCT03374462
Type 1 Diabetes Telemedicine
A study testing Telemedicine Intervention in people with Diabetes Mellitus, Type 1, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Telemedicine Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients and parents whose primary language is not English
- Patients who have Western Health Advantage health insurance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: Use of Home-Based Telemedicine to Improve Healthcare Utilization and Outcomes in Pediatric Patients With Poorly Controlled Type 1 Diabetes
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:
Read more
- 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Telemedicine Intervention
- Keywords
- Pediatrics
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine InterventionBehavioural
Home-based telemedicine visits
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Intervention | Experimental | All participants will receive the study intervention, which consists of home-based telemedicine visits with a diabetes specialist, at a frequency determined by the patient's degree of glycemic control (every 4, 6, or 8 weeks). Receives: Behavioral: Telemedicine Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in A1C Levels
Investigators will compare the mean pre-study and mean post-study A1C levels
Measured: 12-months
Secondary outcomes (4)
Increased visit frequency
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
Measured: 24-months
Impact on high-cost health care utilization
Investigators will compare the mean number of ED visits and mean number of diabetes-related hospitalizations for patients in the cohort
Measured: 24-months
Feasibility of home-based telemedicine
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
Measured: 12-months
Acceptability of home-based telemedicine
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start27 Nov 2017
- Primary completion1 Apr 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Crossen, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374462
- Sponsor's protocol ID
- 1125857
- Status last verified
- Feb 2020
- First submitted
- 27 Nov 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Home-Based Telemedicine to Improve Healthcare Utilization and Outcomes in Pediatric Patients With Poorly Controlled Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03374462
- Acronym / sponsor ID
- 1125857
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Intervention | Experimental | Behavioral: Telemedicine InterventionAll participants will receive the study intervention, which consists of home-based telemedicine visits with a diabetes specialist, at a frequency determined by the patient's degree of glycemic control (every 4, 6, or 8 weeks). |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients and parents whose primary language is not English
- Patients who have Western Health Advantage health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine InterventionHome-based telemedicine visits | Behavioural | Telemedicine Intervention |
Primary outcome
Improvement in A1C Levels
Time frame: 12-months
Investigators will compare the mean pre-study and mean post-study A1C levels
4 secondary outcomes
Increased visit frequency
Time frame: 24-months
Impact on high-cost health care utilization
Time frame: 24-months
Feasibility of home-based telemedicine
Time frame: 12-months
Acceptability of home-based telemedicine
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Crossen, MD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Intervention in people with Diabetes Mellitus, Type 1, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in A1C Levels (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.