A telemedicine-based approach with real-time transmission of blood glucose data improves metabolic control in insulin-treated diabetes: the DIAMONDS randomized clinical trial.


Journal

Journal of endocrinological investigation
ISSN: 1720-8386
Titre abrégé: J Endocrinol Invest
Pays: Italy
ID NLM: 7806594

Informations de publication

Date de publication:
Sep 2022
Historique:
received: 16 01 2022
accepted: 05 04 2022
pubmed: 28 4 2022
medline: 11 8 2022
entrez: 27 4 2022
Statut: ppublish

Résumé

To evaluate if a web-based telemedicine system (the Glucoonline This was a prospective, randomized, controlled trial, carried out at three tertiary referral centers for diabetes in Italy. Adults with insulin-treated type 1 and type 2 diabetes, inadequate glycemic control, and no severe diabetes-related complications and/or comorbidities were eligible for this study. Patients were randomized to either perform telemedicine-assisted (Group A) or standard (Group B) self-monitoring blood glucose (SMBG) for 6 months. In Group A, patients received prompt feedback about their blood glucose levels and therapy suggestions from the study staff via phone/SMS, when appropriate. In Group B, patients had no remote assistance from the study staff between planned visits. 123 patients were included in the final analysis. After 6 months, patients achieved a significant reduction in HbA1c in Group A (-0.38%, p < 0.05) but not in Group B (+ 0.08%, p = 0.53). A significant difference in the percentage of patients with HbA1c < 7% between Group A and Group B was found after 3 months (28.6% vs 11.1%, p = 0.02). Also, fewer patients (p < 0.05) with HbA1c > 8.5% were found in Group A vs Group B, respectively, after both 3 months (14.3% vs 35.2%) and 6 months (21.8% vs 42.9%). The use of the Glucoonline™ system resulted in improved metabolic control. Telemedicine services have potential to support diabetes self-management and provide the patients with remote, prompt assistance using affordable technological equipment. Trial registration This study was registered at clinicaltrials.gov (NCT01804803) on March 5, 2013.

Identifiants

pubmed: 35476320
doi: 10.1007/s40618-022-01802-w
pii: 10.1007/s40618-022-01802-w
pmc: PMC9044385
doi:

Substances chimiques

Blood Glucose 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Insulin 0
Diamond 7782-40-3

Banques de données

ClinicalTrials.gov
['NCT01804803']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1663-1671

Informations de copyright

© 2022. The Author(s).

Références

Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329(14):977–986
doi: 10.1056/NEJM199309303291401
Nathan DM, McKitrick C, Larkin M, Schaffran R, Singer DE (1996) Glycemic control in diabetes mellitus: have changes in therapy made a difference? Am J Med 100(2):157–163
doi: 10.1016/S0002-9343(97)89453-3
Scavini M, Bosi E, Ceriello A, Giorgino F, Porta M, Tiengo A, Vespasiani G, Bottalico D, Marino R, Parkin C, Bonizzoni E, Cucinotta D (2013) Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention. Acta Diabetol 50(5):663–672
doi: 10.1007/s00592-011-0357-y
American Diabetes Association (2017) Glycemic targets. Sec 6 in standards of medical care in diabetes 2017 diabetes Care 40(Suppl 1)
Associazione Medici Diabetologi (AMD)-Società Italiana di Diabetologia (SID) (2018) Standard italiani per la cura del diabete mellito 2018. https://aemmedi.it/wp-content/uploads/2009/06/AMD-Standard-unico1.pdf . Accessed 14 June, 2020
Hortensius J, Kleefstra N, Houweling ST, van der Bijl JJ, Gans RO, Bilo HJ (2012) What do professionals recommend regarding the frequency of self-monitoring of blood glucose? Neth J Med 70(6):287–291
pubmed: 22859424
Mannucci E, Antenore A, Giorgino F, Scavini M (2018) effects of structured versus unstructured self-monitoring of blood glucose on glucose control in patients with non-insulin-treated type 2 diabetes: a meta-analysis of randomized controlled trials. J Diabetes Sci Technol 12(1):183–189
doi: 10.1177/1932296817719290
Parkin CG, Buskirk A, Hinnen DA, Axel-Schweitzer M (2012) Results that matter: structured vs. unstructured self-monitoring of blood glucose in type 2 diabetes. Diabetes Res Clin Pract 97(1):6–15
doi: 10.1016/j.diabres.2012.03.002
Grant RW, Huang ES, Wexler DJ, Laiteerapong N, Warton ME, Moffet HH, Karter AJ (2015) Patients who self-monitor blood glucose and their unused testing results. Am J Manag Care 21(2):e119–e129
pubmed: 25880487 pmcid: 4430190
Associazione Medici Diabetologi (AMD)—Società Italiana di Diabetologia (SID) (2010) Standard italiani per la cura del diabete mellito 2009–2010. Infomedica—Formazione & Informazione Medica; 2010. 150 p. https://aemmedi.it/files/PDF/2010_linee_guida.pdf . Accessed 14 Jun 2020
Kovatchev BP, Cox DJ, Gonder-Frederick LA, Clarke W (1997) Symmetrization of the blood glucose measurement scale and its applications. Diabetes Care 20(11):1655–1658
doi: 10.2337/diacare.20.11.1655
Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke W (1998) Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21(11):1870–1875
doi: 10.2337/diacare.21.11.1870
Kovatchev BP, Otto E, Cox D, Gonder-Frederick L, Clarke W (2006) Evaluation of a newmeasure blood glucose variability in diabetes. Diabetes Care 29(11):2433–2438
doi: 10.2337/dc06-1085
Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR (2010) Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care 33(3):478–484
doi: 10.2337/dc09-1012
Tchero H, Kangambega P, Briatte C, Brunet-Houdard S, Retali GR, Rusch E (2019) clinical effectiveness of telemedicine in diabetes mellitus: a meta-analysis of 42 randomized controlled trials. Telemed J Eng Health 25(7):569–583
doi: 10.1089/tmj.2018.0128
Su D, Zhou J, Kelley MS, Michaud TL, Siahpush M, Kim J, Wilson F, Stimpson JP, Pagán JA (2016) Does telemedicine improve treatment outcomes for diabetes? A meta-analysis of results from 55 randomized controlled trials. Diabetes Res Clin Pract 116:136–148
doi: 10.1016/j.diabres.2016.04.019
Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL (2013) Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS ONE 8(11):e79246
doi: 10.1371/journal.pone.0079246
Toma T, Athanasiou T, Harling L, Darzi A, Ashrafian H (2014) Online social networking services in the management of patients with diabetes mellitus: systematic review and meta-analysis of randomised controlled trials. Diabetes Res Clin Pract 106(2):200–211
doi: 10.1016/j.diabres.2014.06.008
Angeles RN, Howard MI, Dolovich L (2011) The effectiveness of web-based tools for improving blood glucose control in patients with diabetes mellitus: a meta-analysis. Can J Diabetes 35(4):344–352
doi: 10.1016/S1499-2671(11)54011-0
Rodríguez-Idígoras MI, Sepúlveda-Muñoz J, Sánchez-Garrido-Escudero R, Martínez-González JL, Escolar-Castelló JL, Paniagua-Gómez IM, Bernal-López R, Fuentes-Simón MV, Garófano-Serrano D (2009) Telemedicine influence on the follow-up of type 2 diabetes patients. Diabetes Technol Ther 11(7):431–437
doi: 10.1089/dia.2008.0114
Rossi MC, Nicolucci A, Di Bartolo P, Bruttomesso D, Girelli A, Ampudia FJ, Kerr D, Ceriello A, Mayor Cde L, Pellegrini F, Horwitz D, Vespasiani G (2010) Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study. Diabetes Care 33(1):109–115
doi: 10.2337/dc09-1327
Jordan RE, Lancashire RJ, Adab P (2011) An evaluation of Birmingham Own Health telephone care management service among patients with poorly controlled diabetes. A retrospective comparison with the General Practice Research Database. BMC Public Health. https://doi.org/10.1186/1471-2458-11-707
doi: 10.1186/1471-2458-11-707 pubmed: 22111590 pmcid: 3267779
Orsama AL, Lähteenmäki J, Harno K, Kulju M, Wintergerst E, Schachner H, Stenger P, Leppänen J, Kaijanranta H, Salaspuro V, Fisher WA (2013) Active assistance technology reduces glycosylated hemoglobin and weight in individuals with type 2 diabetes: results of a theory-based randomized trial. Diabetes Technol Ther 15(8):662–669
doi: 10.1089/dia.2013.0056
Davis RM, Hitch AD, Salaam MM, Herman WH, Zimmer-Galler IE, Mayer-Davis EJ (2010) TeleHealth improves diabetes self-management in an underserved community: diabetes TeleCare. Diabetes Care 33(8):1712–1717
doi: 10.2337/dc09-1919
Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY (2013) Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc 20(3):526–534
doi: 10.1136/amiajnl-2012-001263
Chumbler NR, Mann WC, Wu S, Schmid A, Kobb R (2004) The association of home-telehealth use and care coordination with improvement of functional and cognitive functioning in frail elderly men. Telemed J E Health 10(2):129–137
doi: 10.1089/tmj.2004.10.129
Barlow J, Singh D, Bayer S, Curry R (2007) A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare 13(4):172–179
doi: 10.1258/135763307780908058
Ghosh A, Gupta R, Misra A (2020) Telemedicine for diabetes care in India during COVID19 pandemic and national lockdown period: Guidelines for physicians. Diabetes Metab Syndr 14(4):273–276
doi: 10.1016/j.dsx.2020.04.001
Associazione Medici Diabetologi (AMD)—Società Italiana di Diabetologia (SID)-Società Italiana di Endocrinologia (SIE). Emergenza Covid-19 Percorso visite ambulatoriali di controllo nei centri di Diabetologia (che già seguono la persona con diabete). www.siditalia.it/pdf/coronavirus/PDTA%20Emergenza%20COVID%20e%20telemedicina_01_04_20.pdfd . Accessed 14 Jun 2020

Auteurs

S Di Molfetta (S)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

P Patruno (P)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

S Cormio (S)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

A Cignarelli (A)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

R Paleari (R)

Department of Physiopathology and Transplantation, Center for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy.

A Mosca (A)

Department of Physiopathology and Transplantation, Center for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy.

O Lamacchia (O)

Section of Endocrinology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

S De Cosmo (S)

Section of Internal Medicine, Department of Medical Sciences, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Foggia, Italy.

M Massa (M)

Section of Internal Medicine, Department of Medical Sciences, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Foggia, Italy.

A Natalicchio (A)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

S Perrini (S)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

L Laviola (L)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

F Giorgino (F)

Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy. francesco.giorgino@uniba.it.

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