Skip to main content
OpenTrials
Completed

NCT Number: NCT02049359

Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics

The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvest Family Health Center, Elm City, North Carolina, United States

Loading trial locations.

About this study

This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C >9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)
  • Diagnosis of diabetes
  • Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment
  • Below 200% of 2013 poverty level
  • Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period

Exclusion criteria

  • Anemia diagnosed within past 3 months
  • Blood transfusion within the past 3 months
  • unable to read English at the fifth grade level

Treatment and study plan

Texting

Other

Bidirectional texting once weekly for 12 weeks

Primary outcomes

  1. Change From Baseline A1C

    Time frame: 12 weeks

    Change in A1C from baseline

Secondary outcomes

  1. Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes

    Time frame: 12 weeks

    Change in A1C from baseline based on age, gender, race, type and duration of diabetes

Sponsors and collaborators

Lead sponsor

Campbell University, Incorporated

Other

Registry information

Official study title

Use of a Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetic Patients (SAMI TRIAL)

Acronym: SAMI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2014
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.