Diabetes MellitusNCT03719911
Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
A study testing Live diabetes coaching program in people with Diabetes Mellitus, run by Welkin Health at 1 site in United States.
Trial summary
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Live diabetes coaching program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2018to 1 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lives in the United States
- Speaks and understands English
- Has a Type 2 diabetes mellitus diagnosis
- Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app
- Has a verified A1c ≥ 8%
- Willing to participate in coaching program
Who cannot join
- Uses a continuous glucose monitoring device
- Currently pregnant
- Unable to make lifestyle behavioral changes due to a cognitive or physical disability
- Has end stage renal disease (ESRD) diagnosis
- Is not able to read or understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.
Read the detailed description
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts.
The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.
- Conditions
- Diabetes Mellitus
- Being tested
- Live diabetes coaching program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live diabetes coaching programBehavioural
Live diabetes coaching program
| Study group | Role | What they receive |
|---|---|---|
| Live diabetes coaching program | Experimental | Live diabetes coaching program Receives: Behavioral: Live diabetes coaching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Blood serum test to measure glucose control
Measured: A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start5 Aug 2018
- Primary completion25 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm 24-week pre-post study
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Welkin Health
- Sponsor type
- University, hospital or other
- Collaborators
- LifeScan
- Responsible party
- Principal investigator, Kristin Neland, Welkin Health
- Investigators
- Kristin Neland, BSN, MPH, Principal investigator, Welkin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719911
- Sponsor's protocol ID
- OTR_COACHING1
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will not share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT03719911
- Acronym / sponsor ID
- OTR_COACHING1
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Welkin HealthUniversity, hospital or other
- Collaborators
- LifeScan
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Oct 2018 (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.
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.
Detailed description
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts.
The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm 24-week pre-post study
| Arm | Type | Receives |
|---|---|---|
| Live diabetes coaching program | Experimental | Behavioral: Live diabetes coaching programLive diabetes coaching program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lives in the United States
- Speaks and understands English
- Has a Type 2 diabetes mellitus diagnosis
- Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app
- Has a verified A1c ≥ 8%
Key exclusion criteria (5 listed)
- Uses a continuous glucose monitoring device
- Currently pregnant
- Unable to make lifestyle behavioral changes due to a cognitive or physical disability
- Has end stage renal disease (ESRD) diagnosis
- Is not able to read or understand English
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 |
|---|---|---|
| Live diabetes coaching programLive diabetes coaching program | Behavioural | Live diabetes coaching program |
Primary outcome
Change in Hemoglobin A1c
Time frame: A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study
Blood serum test to measure glucose control
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 6 Sep 2019.
- Individual participant dataSharing planned: No. Investigators will not share IPD with other researchers
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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.
Kristin Neland, BSN, MPH principal investigator
Welkin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live diabetes coaching program in people with Diabetes Mellitus, run by Welkin Health 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 5 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 6 Sep 2019. 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?
Change in Hemoglobin A1c (time frame: A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study). 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 6 Sep 2019.