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A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes

NCT03224234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-01-22

Study results available
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Summary

Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.

Conditions

Interventions

DEVICE

Insulclock with feedback

Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.

DEVICE

Insulclock without feedback

Not feedback on insulin administration.

Sponsors & Collaborators

  • Insulcloud S.L.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Guillermo Umpierrez, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2019-09-18
Completion
2019-09-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03224234 on ClinicalTrials.gov