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Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03719911
Enrollment
72
Registered
2018-10-25
Start date
2018-08-05
Completion date
2019-07-01
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

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.

Interventions

BEHAVIORALLive diabetes coaching program

Live diabetes coaching program

Sponsors

LifeScan
CollaboratorINDUSTRY
Welkin Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

single-arm 24-week pre-post study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin A1cA1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the studyBlood serum test to measure glucose control

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026