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
| Sponsors |
Lead Sponsor: Welkin Health Collaborator: LifeScan |
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| Source | Welkin Health | ||||||
| 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. |
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| 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. |
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| Overall Status | Completed | ||||||
| Start Date | August 5, 2018 | ||||||
| Completion Date | July 1, 2019 | ||||||
| Primary Completion Date | June 25, 2019 | ||||||
| Phase | N/A | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Enrollment | 72 | ||||||
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| Intervention |
Intervention Type: Behavioral Intervention Name: Live diabetes coaching program Description: Live diabetes coaching program Arm Group Label: Live diabetes coaching program |
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| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: Accepts Healthy Volunteers |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
September 2019 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Welkin Health Investigator Full Name: Kristin Neland Investigator Title: Clinical Program Designer |
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| Has Expanded Access | No | ||||||
| Number Of Arms | 1 | ||||||
| Arm Group |
Label: Live diabetes coaching program Type: Experimental Description: Live diabetes coaching program |
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| Patient Data | No | ||||||
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: single-arm 24-week pre-post study Primary Purpose: Treatment Masking: None (Open Label) |
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