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      The Diabeo Software Enabling Individualized Insulin Dose Adjustments Combined With Telemedicine Support Improves HbA 1c in Poorly Controlled Type 1 Diabetic Patients : A 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study)

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          Abstract

          OBJECTIVE

          To demonstrate that Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support significantly improves HbA 1c in poorly controlled type 1 diabetic patients.

          RESEARCH DESIGN AND METHODS

          In a six-month open-label parallel-group, multicenter study, adult patients ( n = 180) with type 1 diabetes (>1 year), on a basal-bolus insulin regimen (>6 months), with HbA 1c ≥8%, were randomized to usual quarterly follow-up (G1), home use of a smartphone recommending insulin doses with quarterly visits (G2), or use of the smartphone with short teleconsultations every 2 weeks but no visit until point end (G3).

          RESULTS

          Six-month mean HbA 1c in G3 (8.41 ± 1.04%) was lower than in G1 (9.10 ± 1.16%; P = 0.0019). G2 displayed intermediate results (8.63 ± 1.07%). The Diabeo system gave a 0.91% (0.60; 1.21) improvement in HbA 1c over controls and a 0.67% (0.35; 0.99) reduction when used without teleconsultation. There was no difference in the frequency of hypoglycemic episodes or in medical time spent for hospital or telephone consultations. However, patients in G1 and G2 spent nearly 5 h more than G3 patients attending hospital visits.

          CONCLUSIONS

          The Diabeo system gives a substantial improvement to metabolic control in chronic, poorly controlled type 1 diabetic patients without requiring more medical time and at a lower overall cost for the patient than usual care.

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          Most cited references15

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          Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial.

          (2002)
          To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes. Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending "delayed DAFNE" training 6 months later. Secondary care diabetes clinics in three English health districts. 169 adults with type 1 diabetes and moderate or poor glycaemic control. Glycated haemoglobin (HbA(1c)), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL). At 6 months, HbA(1c) was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P<0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t=-5.4, P<0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P<0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in "present quality of life" did not reach significance at 6 months but were significant by 1 year. Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.
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            Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus.

            (2002)
            The purpose of this report is to summarize and integrate the findings of the Diabetes Control and Complications Trial (DCCT), a randomized controlled clinical trial, and the succeeding observational follow-up of the DCCT cohort in the Epidemiology of Diabetes Interventions and Complications (EDIC) study, regarding the effects of intensive treatment on the microvascular complications of type 1 diabetes mellitus. The DCCT proved that intensive treatment reduced the risks of retinopathy, nephropathy, and neuropathy by 35% to 90% compared with conventional treatment. The absolute risks of retinopathy and nephropathy were proportional to the mean glycosylated hemoglobin (HbA(1c)) level over the follow-up period preceding each event. Intensive treatment was most effective when begun early, before complications were detectable. These risk reductions, achieved at a median HbA(1c) level difference of 9.1% for conventional treatment vs 7.3% for intensive treatment have been maintained through 7 years of EDIC, even though the difference in mean HbA(1c) levels of the 2 former randomized treatment groups was only 0.4% at 1 year (P<.001) (8.3% in the former conventional treatment group vs 7.9% in the former intensive treatment group), continued to narrow, and became statistically nonsignificant by 5 years (8.1% vs 8.2%, P =.09). The further rate of progression of complications from their levels at the end of the DCCT remains less in the former intensive treatment group. Thus, the benefits of 6.5 years of intensive treatment extend well beyond the period of its most intensive implementation. Intensive treatment should be started as soon as is safely possible after the onset of type 1 diabetes mellitus and maintained thereafter, aiming for a practicable target HbA(1c) level of 7.0% or less.
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              Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring.

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                Author and article information

                Journal
                Diabetes Care
                diacare
                dcare
                Diabetes Care
                Diabetes Care
                American Diabetes Association
                0149-5992
                1935-5548
                March 2011
                17 February 2011
                : 34
                : 3
                : 533-539
                Affiliations
                [1] 1Department of Diabetes and the Centre d’Études et de Recherche pour l’Intensification du Traitement du Diabète, Sud-Francilien Hospital, Corbeil-Essonnes, France
                [2] 2Department of Endocrinology, University Hospital, Grenoble, France
                [3] 3Department of Endocrinology, University Hospital, Besançon, France
                [4] 4University Hospital Sainte Marguerite, Marseille, France
                [5] 5Department of Endocrinology, CHU Bordeaux, Pessac, France
                [6] 6Department of Diabetology, Toulouse Rangueil University Hospital, Toulouse, France
                [7] 7Clinique d’Endocrinologie, Maladies Métaboliques et Nutrition, Institut du Thorax, Hôpital Laennec, Nantes, France
                [8] 8Endocrinology Department, Centre Hospitalier Universitaire de Montpellier, Université de Montpellier, Montpellier, France
                [9] 9CIC-INSERM, Grenoble University Hospital, Grenoble, France
                Author notes
                Corresponding author: Guillaume Charpentier, kerbonac@ 123456free.fr .

                J.-L.B. and A.P. contributed equally to this work.

                Article
                1259
                10.2337/dc10-1259
                3041176
                21266648
                137c4a4a-ddaa-45f3-9dc1-1c34add528a3
                © 2011 by the American Diabetes Association.

                Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

                History
                : 2 July 2010
                : 5 December 2010
                Categories
                Original Research
                Clinical Care/Education/Nutrition/Psychosocial Research

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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