Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes

NCT03084900 | Completed

• 2 other identifiers: 16123948021DP3DK113183-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c value

  Measure of HbA1c value for youth subjects

  4 years

Secondary Outcomes (2)

• Hypoglycemia

  4 years

• DKA

  4 years

Study Arms (2)

Patient-Centered Decision Support

EXPERIMENTAL

Intervention - computer decision support in diabetes clinic. Investigators will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures. The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.

Other: Arm 1

Standard Care

NO INTERVENTION

Standard pediatric diabetes care will be compared to the computerized decision support system.

Interventions

Arm 1 OTHER

Patient-Centered Decision Support to Improve Diabetes Mgmt. We will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures.The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.

Patient-Centered Decision Support

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents with type 1 diabetes
• Parents of adolescents with type 1 diabetes
• Friends/siblings of adolescents with type 1 diabetes
• Community partners who work with adolescents with type 1 diabetes
• Diabetes care providers

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tamara Hannon, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention Arm 1 versus standard care.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 21, 2017
• Study Start: July 27, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)