NCT02336217

Brief Summary

The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
1mo left

Started Sep 2014

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress99%
Sep 2014Jun 2026

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 23, 2025

Status Verified

November 1, 2024

Enrollment Period

11.8 years

First QC Date

November 14, 2014

Last Update Submit

May 20, 2025

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of hypoglycemic episodes

    6 months

Secondary Outcomes (3)

  • A1c level

    6 months

  • Number of Emergency Room, Urgent Care, or Walk-In Clinic visits

    6 months

  • ADDQOL score

    6 months

Study Arms (2)

Functioning App

EXPERIMENTAL

These subjects have the complete algorithm functioning and communicated via the App.

Other: Experimental Group instructions for glucose management via App

Non-functioning App

PLACEBO COMPARATOR

These subjects receive routine instructions via the App but not the complete algorithm.

Other: Placebo Comparator general instructions

Interventions

Experimental Group instructions for glucose management via AppOTHER

The Experimental Group receives individually calculated instructions for glucose management management via the App.

Functioning App
Placebo Comparator general instructionsOTHER

The Placebo Comparator Group receives general instructions but not the complete management algorithm

Non-functioning App

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes on therapeutic treatment other than just lifestyle changes
  • Treatment by Marshall Internal Medicine Department
  • Have a smart phone
  • At least 6th grade education level

You may not qualify if:

  • Pregnant women
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marshall Health

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, section of Endocrinology

Study Record Dates

First Submitted

November 14, 2014

First Posted

January 12, 2015

Study Start

September 1, 2014

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 23, 2025

Record last verified: 2024-11

Locations

US(1)