Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

Abstract

BackgroundDiabetes 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.MethodsWe 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.ResultsAverage 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.ConclusionsAlthough 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.Trial registrationClinicaltrials.gov Identifier: NCT01221090.

Effectiveness of Internet-Based Interventions on Glycemic Control in Patients With Type 2 Diabetes: Meta-Analysis of Randomized Controlled Trials (Preprint)

“…Some studies only presented changes of HbA1c and in this case HbA1c values in different intervention periods and endpoint were calculated correspondingly based on baseline and changes of values [8,16,[18][19][20]. For studies that provided standard error (SE) rather than SD, SD value was deduced based on SE value [12,[21][22][23].…”

“…Some studies gave 95% confidence interval (CI) of mean HbA1c and SD was derived according to 95% CI [14,18,24]. If neither endpoint SD nor other information that could be used to deduce SD was provided, baseline SD was adopted as endpoint SD [19,25]. Cochrane collaboration's tool for assessing risk of bias was adopted to evaluate the quality of studies included.…”

“…Of the 28 studies included, 9 were conducted in the United States [11,12,19,20,22,25,28,30,31], 7 in the Republic of Korea [7,8,21,23,26,27,37], 2 in Poland [29,36] and Italy [16,35] respectively and 1 in China [34], Japan [33], Finland [18], Turkey [10], Canada [9], Spain [24], Norway [14] and England [32] each. Included studies were published between 2004 and 2016 and the intervention duration ranged from 6 weeks to 5 years.…”

“…10 studies utilized other forms of new media, including portable digital assistant, tablet computer and data transmission equipment only [11,16,19,20,22,23,25,28,32,35]. 21 studies clearly stated ways of providing feedbacks, among which 4 utilized automated algorithm [18,27,30,37] and 17 provided factitious feedbacks [7, 9-11, 14, 20-26, 28, 31, 32, 34, 35].…”

Impact of chronic disease self-management programs on type 2 diabetes management in primary care

“…The flow diagram of participant enrollment and disposition in the trial has been described elsewhere [31] . Of the subjects randomized, 101 entered the CDSMP arm and 95 entered the control arm.…”