NCT02980978

Brief Summary

This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED randomized control trial. The study is being conducted by the Minneapolis Heart Institute Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND). The study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual care. The D5 goals include: blood pressure \<140/90 mmHg, taking a statin as appropriate, A1c \<8%, not using tobacco and taking an aspirin as appropriate.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed
Last Updated

July 29, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

November 15, 2016

Results QC Date

May 30, 2019

Last Update Submit

May 30, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • A1c (Laboratory Assessment)

    The count of participants represents the number of individuals meeting A1c less than 8% at follow up

    1 year

Other Outcomes (4)

  • Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)

    1 year

  • Tobacco Use (Self-reported Questionnaire)

    1 year

  • Statin Use (as Noted in EMR)

    1 year

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals

Behavioral: Coaching

Standard of Care

NO INTERVENTION

Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need

Interventions

CoachingBEHAVIORAL

Focus on nutrition, activity and appropriate medication use and adherence

Intervention

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Diabetes
  • Individuals who are not meeting 3 or more D5 goals,
  • Have had a visit with a provider within the last 2 years

You may not qualify if:

  • Type 1 Diabetes
  • Chronic kidney disease (GFR \<30)
  • HIV
  • Institutional residence
  • Major cognitive or language barrier (as determined by program enrollment staff)
  • Other active end-stage disease (e.g., late stage cancer or pulmonary disease)
  • Actively receiving cancer treatment
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Benson GA, Sidebottom A, Hayes J, Miedema MD, Boucher J, Vacquier M, Sillah A, Gamam S, VanWormer JJ. Impact of ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes) Telemedicine Randomized Controlled Trial on Diabetes Optimal Care Outcomes in Patients with Type 2 Diabetes. J Acad Nutr Diet. 2019 Apr;119(4):585-598. doi: 10.1016/j.jand.2018.11.013. Epub 2019 Jan 31.

    PMID: 30711463DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Population Health Program Manager
Organization
Minneapolis Heart Institute Foundation
gbenson@mhif.org
612-863-4222

Study Officials

  • Michael Miedema, MD

    Minneapolis Heart Institute Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

December 2, 2016

Study Start

April 1, 2016

Primary Completion

December 13, 2017

Study Completion

November 13, 2018

Last Updated

July 29, 2019

Results First Posted

July 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share