Impact of the “Diabetes Interactive Diary” Telemedicine System on Metabolic Control,Risk of Hypoglycemia,and Quality of Life: A Randomized Clinical Trial in Type 1 Diabetes
Restricted accessResearch articleFirst published online August, 2013
Impact of the “Diabetes Interactive Diary” Telemedicine System on Metabolic Control,Risk of Hypoglycemia,and Quality of Life: A Randomized Clinical Trial in Type 1 Diabetes
Telemedicine systems based on mobile phones represent new promising educational tools. The “Diabetes Interactive Diary” (DID) is a carbohydrate/bolus calculator promoting the patient–physician communication via short message service. This study aimed to compare the efficacy of the DID versus usual care on metabolic control, hypoglycemia, and quality of life.
Patients and Methods:
Patients with type 1 diabetes on a basal:bolus regimen with insulin glargine and insulin glulisine, not previously educated on carbohydrate (CHO) counting, were randomized to DID (Group A; n=63) or traditional education (Group B; n=64). Generalized hierarchical linear regression models for repeated measures were applied to compare changes between groups. Incidence of hypoglycemia was compared using Poisson regression models.
Results:
Of 127 patients (age, 36.9±10.5 years; diabetes duration, 16.3±9.3 years), 15 (11.8%) dropped out. After 6 months, hemoglobin A1c (HbA1c) levels decreased by −0.49±0.11 in Group A and −0.48±0.11 in Group B (P=0.73). Group A showed a 86% lower risk of grade 2 hypoglycemia than Group B. Compared with usual care, DID improved the “perceived frequency of hyperglycemic episodes” scale of the Diabetes Treatment Satisfaction Questionnaire and the “social relations” and the “fear of hypoglycemia” dimensions of the Diabetes Specific Quality of Life Scale. Results obtained with DID markedly differ among patients and centers.
Conclusions:
DID is no more effective than traditional CHO counting education in reducing HbA1c levels. DID reduces the risk of moderate/severe hypoglycemia and improves quality of life. A better understanding of patients' and healthcare professionals' attitudes associated with an effective care supported by technology is essential to avoid waste of resources.
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References
1.
FranzMJ, BantleJP, BeebeCA, BrunzellJD, ChiassonJL, GargA, HolzmeisterLA, HoogwerfB, Mayer-DavisE, MooradianAD, PurnellJQ, WheelerM. Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care, 2002; 25:148–198.
2.
American Diabetes Association. BantleJP, Wylie-RosettJ, AlbrightAL, ApovianCM, ClarkNG, FranzMJ, HoogwerfBJ, LichtensteinAH, Mayer-DavisE, MooradianAD, WheelerML. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care, 2008; 31,Suppl 1:S61–S78.
3.
CiminoA, FavaD, GiordaC, MeloncelliI, NicolucciA, PellegriniF, RossiMC, TurcoS, VespasianiG. AMD Annals 2010—Quality Indicators in Diabetes Care in Italy. Torino: Ed. Kino, 2010. www.infodiabetes.it/files/ANNALI-AMD/2010/Annali%202010%20inglese.pdf. 2013 February 25.
4.
WheelerML, Pi-SunyerFX. Carbohydrate issues: type and amount. J Am Diet Assoc, 2008; 108,4 Suppl 1:S34–S39.
5.
American Diabetes Association:. Third-party reimbursement for diabetes care, self-management education, and supplies. Diabetes Care, 2003; 26,Suppl 1:S143–S144.
6.
RubinRR, PeyrotM, SiminerioLM. Health care and patient-reported outcomes: results of the cross-national Diabetes Attitudes, Wishes and Needs (DAWN) study. Diabetes Care, 2006; 29:1249–1255.
7.
BarnardKD, PeyrotM, HoltRI. Psychosocial support for people with diabetes: past, present and future. Diabet Med, 2012; 29:1358–1360.
8.
CampbellRK. Recommendations for improving adherence to type 2 diabetes mellitus therapy—focus on optimizing insulin-based therapy. Am J Manag Care, 2012; 18,3 Suppl:S55–S61.
9.
HopkinsD, LawrenceI, MansellP, ThompsonG, AmielS, CampbellM, HellerS. Improved biomedical and psychological outcomes 1 year after structured education in flexible insulin therapy for people with type 1 diabetes: the U.K. DAFNE experience. Diabetes Care, 2012; 35:1638–1642.
10.
GillespieSJ, KulkarniKD, DalyAE. Using carbohydrate counting in diabetes clinical practice. J Am Diet Assoc, 1998; 98:897–905.
11.
National Institute for Clinical Excellence: Guidance on the use of patient-education models for diabetes. www.nice.org.uk/nicemedia/live/11496/32610/32610.pdf. 2013 May 8.
12.
DAFNE Study Group:. 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. BMJ, 2002; 325:746–757.
KlonoffDC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical?Diabetes Care, 2003; 26:1626–1628.
15.
HitmanGA. Mobile phone intervention for diabetes. Diabet Med, 2011; 28:381.
16.
FarmerA, GibsonOJ, TarassenkoL, NeilA. A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes. Diabet Med, 2005; 22:1372–1378.
17.
MairF, WhittenP. Systematic review of studies of patient satisfaction with telemedicine. BMJ, 2000; 320:1517–1520.
18.
LiangX, WangQ, YangX, CaoJ, ChenJ, MoX, HuangJ, WangL, GuD. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med, 2011; 28:455–463.
19.
RossiMCE, NicolucciA, Di BartoloP, HorwitzD, VespasianiG. The Diabetes Interactive Diary—a useful tool for diabetes management?Eur Endocrinol, 2010; 6:39–42.
20.
RossiMC, NicolucciA, PellegriniF, BruttomessoD, Di BartoloP, MarelliG, Dal PosM, GalettaM, HorwitzD, VespasianiG. Interactive Diary for Diabetes: a useful and easy-to-use new telemedicine system to support the decision-making process in type 1 diabetes. Diabetes Technol Ther, 2009; 11:19–24.
21.
RossiMC, NicolucciA, Di BartoloP, BruttomessoD, GirelliA, AmpudiaFJ, KerrD, CerielloA, Mayor CdeL, PellegriniF, HorwitzD, VespasianiG. 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, 2010; 33:109–115.
22.
BradleyC. Diabetes Treatment Satisfaction Questionnaire (DTSQ)Handbook of Psychology and Diabetes. Chur, Switzerland: Harwood, 1994; 111–132.
23.
NicolucciA, GiorginoR, CucinottaD, ZoppiniG, MuggeoM, SquatritoS, CorsiA, LostiaS, PappalardoL, BenaduceE, GirelliA, GaleoneF, MaldonatoA, PerrielloG, PataP, MarraG, CoronelGA. Validation of the Italian version of the WHO-Well-Being Questionnaire (WHO-WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ)Diabetes Nutr Metab, 2004; 17:235–243.
24.
WareJEJr, SherbourneCD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care, 1992; 30:473–483.
25.
ServiceFJ, MolnarGD, RosevearJW, AckermanE, GatewoodLC, TaylorWF. Mean amplitude of glycaemic excursions, a measure of diabetic instability. Diabetes, 1970; 19:644–655.
26.
MonnierL, MasE, GinetC, MichelF, VillonL, CristolJP, ColetteC. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA, 2006; 295:1681–1687.
27.
OyiboSO, PrasadYD, JacksonNJ, JudeEB, BoultonAJ. The relationship between blood glucose excursions and painful diabetic peripheral neuropathy: a pilot study. Diabet Med, 2002; 19:870–873.
28.
BottU, MuhlhauserI, OvermannH, BergerM. Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes. Diabetes Care, 1998; 21:757–769.
29.
BottU, EbrahimS. Further development of a quality-of-life measure for IDDM patients [abstract]Diabetologia, 1998; 41:A74.
30.
WareJEJr, GandeckBL, KellerSD. the IQOLA Project Group. Evaluating instruments used cross-nationally: methods from the IQOLA Project. Quality of Life and Pharmacoecoeconomics. Philadelphia: Lippincott-Raven Publishers, 1996; 681–692.
31.
EQuality1 Study Group—Evaluation of QUALITY of Life and Costs in Diabetes Type 1. NicolucciA, MaioneA, FranciosiM, AmorettiR, BusettoE, CapaniF, BruttomessoD, Di BartoloP, GirelliA, LeonettiF, MorviducciL, PonziP, VitacolonnaE. Quality of life and treatment satisfaction in adults with type 1 diabetes: a comparison between continuous subcutaneous insulin injection and multiple daily injections. Diabet Med, 2008; 25:213–220.
32.
WalshJ, RobertsR, BaileyT. Guidelines for optimal bolus calculator settings in adults. J Diabetes Sci Technol, 2011; 5:129–135.
33.
RaveK, KleinO, FrickAD, BeckerRHA. Advantage of premeal-injected insulin glulisine compared with regular human insulin in subjects with type 1 diabetes. Diabetes Care, 2006; 29:1812–1817.
34.
OvermannH, HeinemannL. Injection-meal interval: recommendations of diabetologists and how patients handle it. Diabetes Res Clin Pract, 1999; 43:137–142.
35.
SingerJD, WillettJB. Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press, 2003.
36.
NicolucciA, CucinottaD, SquatritoS, LapollaA, MusacchioN, LeottaS, VitaliL, BulottaA, NicozianiP, CoronelG. QuoLITy Study Group. Clinical and socio-economic correlates of quality of life and treatment satisfaction in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis, 2009; 19:45–53.
37.
SaatciE, TahmisciogluG, BozdemirN, AkpinarE, OzcanS, KurdakH. The well-being and treatment satisfaction of diabetic patients in primary care. Health Qual Life Outcomes, 2010; 8:67.
38.
RoseM, FliegeH, HildebrandtM, SchiropT, KlappBF. The network of psychological variables in patients with diabetes and their importance for quality of life and metabolic control. Diabetes Care, 2002; 25:35–42.
39.
BarnettAH, CradockS, FisherM, HallG, HughesE, MiddletonA. Key considerations around the risks and consequences of hypoglycemia in people with type 2 diabetes. Int J Clin Pract, 2010; 64:1121–1129.
40.
HoltP. Taking hypoglycemia seriously: diabetes, dementia and heart disease. Br J Community Nurs, 2011; 16:246–249.
41.
LeeseGP, WangJ, BroomhallJ, KellyP, MarsdenA, MorrisonW, FrierBM, MorrisAD. DARTS/MEMO Collaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes. Diabetes Care, 2003; 6:1176–1180.
42.
KovatchevBP, CoxDJ, Gonder-FrederickLA, ClarkeWL. Symmetrization of the blood glucose measurement scale and its applications. Diabetes Care, 1997; 20:1655–1658.
43.
KovatchevBP, OttoE, CoxD, Gonder-FrederickL, ClarkeW. Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care, 2006; 29:2433–2438.
44.
MusacchioN, Lovagnini ScherA, GiancateriniA, PessinaL, SalisG, SchivalocchiF, NicolucciA, PellegriniF, RossiMC. Impact of a chronic care model based on patient empowerment on the management of Type 2 diabetes: effects of the SINERGIA programme. Diabet Med, 2011; 28:724–730.
