Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial.
BACKGROUND
Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons.


METHODS
We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model.


RESULTS
Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants' diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups.


CONCLUSIONS
Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control.


BACKGROUND
Clinicaltrials.gov Identifier: NCT01221090.
Department of Family & Community Medicine, Scott & White Healthcare, College of Medicine, Texas A&M Health Science Center, Temple, TX, USA. sforjuoh@sw.org.
Samuel N
SN
Forjuoh
Jane N
JN
Bolin
John C
JC
Huber
Ann M
AM
Vuong
Omolola E
OE
Adepoju
Janet W
JW
Helduser
Dawn S
DS
Begaye
Anne
A
Robertson
Darcy M
DM
Moudouni
Timethia J
TJ
Bonner
Kenneth R
KR
McLeroy
Marcia G
MG
Ory
D000293:Adolescent; D000328:Adult; D000368:Aged; D034201:Computers, Handheld; D003924:Diabetes Mellitus, Type 2 / Q000208:ethnology / Q000628:therapy*; D005006:Ethnicity; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D044469:Racial Groups; D012648:Self Care / Q000379:methods*; D012984:Software; D016896:Treatment Outcome; D055815:Young Adult
D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human