Digital health technology and mobile devices for the management of diabetes mellitus: state of the art

Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. Trial registration ClinicalTrials.gov identifier: NCT02082184. Funding Abbott Diabetes Care. Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users. Show more

  To assess the effect of mobile phone intervention on glycaemic control in diabetes self-management. We searched three electronic databases (PubMed, EMBASE and Cochrane Library) using the following terms: diabetes or diabetes mellitus and mobile phone or cellular phone, or text message. We also manually searched reference lists of relevant papers to identify additional studies. Clinical studies that used mobile phone intervention and reported changes in glycosylated haemoglobin (HbA(1c) ) values in patients with diabetes were reviewed. The study design, intervention methods, sample size and clinical outcomes were extracted from each trial. The results of the HbA(1c) change in the trials were pooled using meta-analysis methods.   A total of 22 trials were selected for the review. Meta-analysis among 1657 participants showed that mobile phone interventions for diabetes self-management reduced HbA(1c) values by a mean of 0.5% [6 mmol/mol; 95% confidence interval, 0.3-0.7% (4-8 mmol/mol)] over a median of 6 months follow-up duration. In subgroup analysis, 11 studies among Type 2 diabetes patients reported significantly greater reduction in HbA(1c) than studies among Type 1 diabetes patients [0.8 (9 mmol/mol) vs. 0.3% (3 mmol/mol); P=0.02]. The effect of mobile phone intervention did not significantly differ by other participant characteristics or intervention strategies.   Results pooled from the included trials provided strong evidence that mobile phone intervention led to statistically significant improvement in glycaemic control and self-management in diabetes care, especially for Type 2 diabetes patients. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK. Show more

Increasingly, low-income inner-city patients with diabetes utilize emergency departments (EDs) for acute and chronic care. We seek to determine whether a scalable, low-cost, unidirectional, text message-based mobile health intervention (TExT-MED) improves clinical outcomes, increases healthy behaviors, and decreases ED utilization in a safety net population. Show more