Clinical trial : Types and Design (Pharmacovigilance)
Diabetes tele-monitoring project
1. Tele-monitoring of blood glucose with nurse feedback: What do patients think?
W Brye¹, MA; B Eichold², MD, DrPH, FACP; S Brown², RN; S Hansberry¹, BS; V Bonner¹, MPM;
E. Crook¹, MD; M Arrieta¹, MD, MPH, PhD
(¹University of South Alabama Center for Healthy Communities ²Mobile County Health Department)
DISCUSSION
While this study is limited by its small sample size (five participants), it provides information on
how a tele-monitoring system may be effective in supporting SMBG, through an increased
awareness of the diabetes medical condition, a greater understanding of the importance of
monitoring blood glucose, and a feeling of direct connection to the health care provision team. It
would be interesting to learn if the feelings of obligation to the study which produced compliance
to study requests may be shifted to a sense of obligation to one’s health and produce better
outcomes in terms of the health of the diabetic patient and management of the diabetes
condition.
INTRODUCTION
Research shows that a collaborative relationship between the diabetic patient and a medical care
team assists in the patient’s understanding and proper management of diabetes. Self monitoring
of blood sugar (SMBG) is considered essential in diabetes management and has been found to
promote glycemic control in insulin-treated Type 2 diabetes patients. Advances in information
technology have given rise to innovative interventions that enable the real-time electronic
transmission of self-measured glucose levels from patients to providers (biotelemetry), thus
facilitating the provision of immediate feedback when glucose levels are outside of an acceptable
range.
METHODS
A focus group discussion was used to gather participants’ views on the benefit of using a system
of glucose tele-monitoring with nurse feedback.
Source population: Focus group participants had been part of the tele-monitoring arm of the nine-month
study “Real-time Tele-monitoring of Glucose as Adjunct to the Management of Type 2
Diabetes in Primary Care Clinics”. The study randomized patients from four primary care settings
to either self-monitoring of glucose and patient initiated report of abnormal glucose readings or
tele-monitoring (that is, real-time report of glucose measurement via a phone-based interactive
voice response system) with automated report of abnormal readings. Both groups received nurse
feedback upon receipt of information on unacceptable glucose values.
Study participants: Five of the fifteen eligible patients who had completed the intervention arm of
the trial participated in the focus group. While we had planned for a random sample of eligible
patients to participate, we shifted to a convenience sample due to the fact that several of the
patients originally selected at random could not be reached and/or declined to participate in the
study.
Focus Group discussion and analysis: After obtaining their informed consent, participants were led
in a discussion which included questions regarding their experiences as participants in the trial
“Real-time Tele-monitoring of glucose as Adjunct to the Management of Type 2 Diabetes in
Primary Care Clinics” and questions related to their management of diabetes, including diet,
medication, and exercise. The discussion was taped and the tapes were transcribed verbatim.
Two analysts (W.B. and M.A.) reviewed the focus group transcript and arrived at a consensus
interpretation of emerging themes relative to the acceptability to patients of the glucose tele-monitoring
system.
RESULTS
The participants included four females and one male. Three of them had a long
standing diagnosis of diabetes (26, 22, and 13 years). Two of the participants
had been diagnosed in the past year.
Selected quotes substantiating our major findings are presented below:
Type 2 diabetes bio-telemetry combined with nurse feedback increased
patients’ understanding of the importance of glucose monitoring and
resulted in increased monitoring activity
“ …when during the study you realize hey I felt alright but my sugar it was
really too high. A lot of times it made me realize I can’t really go by how I feel
all the time because it don’t tell me exactly a true. It don’t tell me it’s not true by
what I feel. It’s something that you really need to check and with the study it
made me. It brought me back to what I should have been doing from the
beginning.”
“I wasn’t real faithful [measuring blood glucose] before the study. I’m more
faithful now than I was before.”
Patients reported an increased awareness of their diabetes
“This study in a whole it made you, it made me more aware of my condition
and how and what I need to do in order to control it.”
“It [call from nurse coordinator] made you think more on what you may eat or do
concerning the glucose level, the disease itself and how to take care of it.”
Patients reported that they had assistance in dealing with their disease
and that someone genuinely cared about their well-being
“I thought it was rather interesting. You think about who is interested in you
today anyway.”
“And one thing about diabetes study, when you’re alone and depressed and
disgusted it comes in handy cause you know you got someone to talk to and
someone that cares.”
“That’s right.”
“It does.”
“She’s [nurse coordinator] really there for you.”
ACKNOWLEDGMENTS: The authors would like to thank Dr. Dan Roach , Ms. Barbie Oliver, and staff at the University of South Alabama Center for Strategic Health Innovations for their
support in the telemonitoring process and to Mobile County Health Department personnel for their unwavering support to the project: Dr. Reuben Belen, Ms. Angelia Blackmon, RN, NP,
Dr. Gregory Evans, Dr. Sumbal Khan, Dr. John Roberts, Dr. Thomasina Sharpe, Dr. Kenneth Sherman, Ms. Susan Stiegler , BSN, MPH; Mr. Frank Mitchell, M Ed, MPA; and Ms.
Kathleen Johnson. This work was supported in part by a grant from Robert Wood Johnson Foundation Finding Answers Disparities Research for Change -award number 64247.
OBJECTIVE
To determine Type 2 insulin dependent diabetes patients’ perceptions of the benefits of a system of biotelemetry
and nurse feedback used to monitor blood glucose
RESULTS (CONTINUED)
Patients commented on the non-judgmental, concerned nature of the feedback
“And she’s [nurse coordinator] not gone tell you nothing negative to try to get you disgusted and
depressed.”
“She [nurse coordinator] really makes you feel good about yourself.”
Compliance with the intervention (calling in blood glucose values) was at times motivated
by a sense of obligation or duty to the study
“You feel like you’re obligated to do it. It’s something you really must do. And I wish I had that
kind of attitude because it is something that you need to do every day.”
Patient acknowledged having, on occasion, avoided sending high glucose values and/or
waiting for the glucose value to return to an acceptable level before calling it in
“If mine was too high I would say oh man I better go get it down then I call it…”
“Like I said mine was really high. Man, I would go to drinking water and I mean I would really get
this stuff down and then start just really start looking at it cause these people might throw me in
the hospital. I don’t wanna go to no hospital.”
Patients felt that they benefited from tele-monitoring
“I love to send mine [glucose measurements] over the phone because if it wasn’t right they would
call me back and let me know so and so…”
“It [tele-monitoring] makes you more aware.”