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A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

ABSTRACT: To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM).Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ?8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center. Unfortunately, the mentored group failed to show significant improvements in HbA1c levels or other outcomes, including the quality of life, after completion of the study. However, the mentored group monitored their blood glucose (1.41 vs. 0.30) and logged into our website (http://ubisens.co.kr/) more frequently (20.59 times vs. 5.07 times) than the control group.A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up. However, the noted increase in the subjects' frequency of blood glucose monitoring may lead to clinical benefits.

SUBMITTER: Suh S

PROVIDER: S-EPMC4021300 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

Suh Sunghwan S Jean Cheol C Koo Mihyun M Lee Sun Young SY Cho Min Ja MJ Sim Kang-Hee KH Jin Sang-Man SM Bae Ji Cheol JC Kim Jae Hyeon JH

Diabetes & metabolism journal 20140418 2

<h4>Background</h4>To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM).<h4>Methods</h4>Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM pat ...[more]

PMID: 24851207

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Project description:BACKGROUND:The popularity of internet as an area of research has grown manifold over the years. Given its rapid development and increasing coverage worldwide, internet-based interventions seem to offer a promising option to ameliorate huge burdens brought by type 2 diabetes mellitus. However, studies conducted by different researchers have provided contradictory results on the effect of internet-based interventions in glycemic control. OBJECTIVE:This meta-analysis aims to summarize currently available evidence and evaluate the overall impact of internet-based interventions on glycemic management of type 2 diabetic patients. METHODS:A systematic literature search was performed in PubMed, ScienceDirect, and Web of Science. Randomized controlled trials that used glycosylated hemoglobin values as the outcome measure of glycemic control were considered. Risk of bias and publication bias were evaluated. RESULTS:Of the 492 studies, 35 were included in meta-analysis, and results indicated that the weighted mean difference (WMD) between usual care and internet-based interventions at endpoint was -0.426% (95% CI -0.540 to -0.312; P<.001). Subgroup analyses revealed that intervention duration ≤3 months yielded optimal performance (WMD -0.51%; 95% CI -0.71 to -0.31; P<.001). Combined mobile and website interventions were substantially superior to solely Web-based and mobile-based interventions in glycemic control (combined WMD -0.77%, 95% CI -1.07 to -0.47; P<.001; Web only: WMD -0.48%; 95% CI -0.71 to -0.24, P<.001; mobile only WMD -0.31%, 95% CI -0.49 to -0.14; P<.001). Furthermore, the effect of interventions with automated feedbacks was similar to those with manual feedbacks, and studies with internet-based educational contents were more effective in glycemic control. The assessment revealed a low risk of bias. CONCLUSIONS:In conclusion, utilization of internet-based intervention is beneficial for patients with type 2 diabetes mellitus, and taking full advantage of this type of intervention may substantially reduce the incidence of complications and improve quality of life. TRIAL REGISTRATION:International Prospective Register of Systematic Reviews (PROSPERO): CRD42017058032; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=58032 (Archived by WebCite at http://www.webcitation.org/6yY7eQNHr).

Project description:IntroductionDaily dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly used with other orally administered antihyperglycemic agents (AHA), as combination therapy, to treat Japanese patients with type 2 diabetes. When combination therapy is indicated, use of a once-weekly (q.w.) orally administered DPP-4 inhibitor might be an appropriate therapeutic option for some patients.MethodsA 52-week trial was conducted to assess the safety and tolerability (primary objectives) and glycemic efficacy (secondary objectives) of the q.w. DPP-4 inhibitor omarigliptin as add-on therapy to five different classes of orally administered AHA [sulfonylurea (SU), glinide (GL), biguanide (BG), thiazolidinedione (TZD), or α-glucosidase inhibitor (AGI)] commonly used in Japan and having different mechanisms of drug action from DPP-4 inhibitors. The trial consisted of an initial 24-week double-blind, placebo-controlled period during which patients (stratified by background AHA) were randomized to omarigliptin 25 mg q.w. or placebo, followed by a 28-week open-label period during which patients on placebo were switched to omarigliptin.ResultsAfter 24 weeks, the percentages of patients with adverse events (AEs), serious AEs, drug-related AEs, AEs of symptomatic hypoglycemia, or who discontinued from trial medication because of an AE were generally similar in the omarigliptin and placebo groups, in all background AHA strata and in the overall population. From a mean baseline HbA1c of approximately 8.0%, the placebo-adjusted least-squares mean changes from baseline ranged from -0.80% (AGI stratum) to -1.16% (TZD stratum); p < 0.001 for all background AHA strata. During the open-label period, no safety signals emerged with longer-term treatment. At week 52, the change from baseline in HbA1c in the omarigliptin/omarigliptin group was similar to that of the placebo/omarigliptin group.ConclusionsAddition of once-weekly omarigliptin to AHA therapy with an SU, GL, BG, TZD, or AGI for up to 52 weeks was generally safe and well tolerated, and provided persistent efficacy.Clinical trial registrationClinicalTrials.gov: NCT01697592.FundingMSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Project description:BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.Methods and findingsWe performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.Trial registrationCurrent Controlled Trials ISRCTN 71674628.

Project description:Acute hyperglycemia delays gastric emptying in patients with diabetes. However, it is not clear whether improved control of glycemia affects gastric emptying in these patients. We investigated whether overnight and short-term (6 mo) improvements in control of glycemia affect gastric emptying.We studied 30 patients with poorly controlled type 2 diabetes (level of glycosylated hemoglobin, >9%). We measured gastric emptying using the [(13)C]-Spirulina platensis breath test on the patients' first visit (visit 1), after overnight administration of insulin or saline, 1 week later (visit 2), and 6 months after intensive therapy for diabetes. We also measured fasting and postprandial plasma levels of C-peptide, glucagon-like peptide 1, and amylin, as well as autonomic functions.At visit 1, gastric emptying was normal in 10 patients, delayed in 14, and accelerated in 6; 6 patients had gastrointestinal symptoms; vagal dysfunction was associated with delayed gastric emptying (P < .05). Higher fasting blood levels of glucose were associated with shorter half-times of gastric emptying (thalf) at visits 1 (r = -0.46; P = .01) and 2 (r = -0.43; P = .02). Although blood levels of glucose were lower after administration of insulin (132 ± 7 mg/dL) than saline (211 ± 15 mg/dL; P = .0002), gastric emptying thalf was not lower after administration of insulin, compared with saline. After 6 months of intensive therapy, levels of glycosylated hemoglobin decreased from 10.6% ± 0.3% to 9% ± 0.4% (P = .0003), but gastric emptying thalf did not change (92 ± 8 min before, 92 ± 7 min after). Gastric emptying did not correlate with plasma levels of glucagon-like peptide 1 and amylin.Two-thirds of patients with poorly controlled type 2 diabetes have mostly asymptomatic yet abnormal gastric emptying. Higher fasting blood levels of glucose are associated with faster gastric emptying. Overnight and sustained (6 mo) improvements in glycemic control do not affect gastric emptying.

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A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

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A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

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