Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)

Telemedicine Clinical Trial

— PLATEDIAN  

Official title:

Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332472
• Other study ID #: PLATEDIAN
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: November 1, 2017
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c <8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.

Description:

The substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses of insulin (MDI) and regular metabolic control (HbA1c <8 %). It even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with DM1

To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1 and regular metabolic control (HbA1c <8%) on MDI treatment in the following parameters:

A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of hospital admissions due to glycemic decompensation / 6 months.

B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).

C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.

F) Costs and consumption of health resources:

-Cost-effectiveness (HbA1C)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: December 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with DM1 over 2 years of evolution.

• Age =18 and <65 years.

• HbA1c prior to inclusion of the study <8% (the measure being valid in the month prior to inclusion in the study)

• Intensive insulin therapy with basal-bolus MDI.

• Patients living in Andalusian

• Patients candidates for telemonitoring.

• Patients who have received written informed consent.

Exclusion Criteria:

• Treatment with ISCI.

• Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).

• Pregnancy or pregnancy planning.

• Diabetes mellitus type 2.

• Severe psychological disturbances.

• Absence of collaboration (informed consent).

• Patients who are participating in other clinical studies.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Telemedicine

Intervention

Other:
• Telemedicine group

• Conventional group

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga. Unidad de Diabetes	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Country where clinical trial is conducted

Spain, 

References & Publications (15)

American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1:S11-63. doi: 10.2337/dc12-s011. Review. — View Citation

Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS, Rondán RM, Carreira M, Domínguez-López M, Machado A, Gonzalo-Marín M, Tapia MJ, Valdés S, González-Romero S, Soriguer FC. Development of a new fear of hypoglycemia scale: FH-15. Psychol Assess. 2011 Jun;23(2):398-405. doi: 10.1037/a0021927. — View Citation

Bellazzi R, Larizza C, Montani S, Riva A, Stefanelli M, d'Annunzio G, Lorini R, Gomez EJ, Hernando E, Brugues E, Cermeno J, Corcoy R, de Leiva A, Cobelli C, Nucci G, Del Prato S, Maran A, Kilkki E, Tuominen J. A telemedicine support for diabetes management: the T-IDDM project. Comput Methods Programs Biomed. 2002 Aug;69(2):147-61. — View Citation

Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28. — View Citation

Biermann E, Dietrich W, Standl E. Telecare of diabetic patients with intensified insulin therapy. A randomized clinical trial. Stud Health Technol Inform. 2000;77:327-32. — View Citation

Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25. — View Citation

Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. — View Citation

Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. — View Citation

Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702. — View Citation

Franc S, Daoudi A, Mounier S, Boucherie B, Dardari D, Laroye H, Neraud B, Requeda E, Canipel L, Charpentier G. Telemedicine and diabetes: achievements and prospects. Diabetes Metab. 2011 Dec;37(6):463-76. doi: 10.1016/j.diabet.2011.06.006. Epub 2011 Sep 1. Review. — View Citation

Gómez EJ, Hernando ME, García A, Del Pozo F, Cermeño J, Corcoy R, Brugués E, De Leiva A. Telemedicine as a tool for intensive management of diabetes: the DIABTel experience. Comput Methods Programs Biomed. 2002 Aug;69(2):163-77. — View Citation

Jansà M, Vidal M, Viaplana J, Levy I, Conget I, Gomis R, Esmatjes E. Telecare in a structured therapeutic education programme addressed to patients with type 1 diabetes and poor metabolic control. Diabetes Res Clin Pract. 2006 Oct;74(1):26-32. Epub 2006 Apr 18. — View Citation

Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94. — View Citation

Rigla M, Hernando ME, Gómez EJ, Brugués E, García-Sáez G, Torralba V, Prados A, Erdozain L, Vilaverde J, de Leiva A. A telemedicine system that includes a personal assistant improves glycemic control in pump-treated patients with type 1 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):505-10. — View Citation

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. 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 Jan;33(1):109-15. doi: 10.2337/dc09-1327. Epub 2009 Oct 6. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Glycosylated hemoglobin	6 months
Secondary	Total daily dose of insulin	total daily doseof insulin (IU/day)	6 months
Secondary	Total daily dose of insulin by weight	Total daily dose by weight (IU / kg / day)	6 months
Secondary	Number of mild hypoglycaemia	Acude complications prior to V1: number of mild hypoglycaemia	6 months
Secondary	Number of severe hypoglycemia	Acute complications prior to V1: number of severe hypoglycemia	6 months
Secondary	Number of hyperglycemia greater than 250 mg / dl / week	Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week	6 months
Secondary	Number of episodes of ketosis number of episodes of ketoacidosis	Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis	6 months
Secondary	Number of hospital admissions due to glycemic decompensations	Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.	6 months
Secondary	Fear of hypoglycemia: FH-15 scale	Hypoglycemia Fear test: FH-15 questionnaire (Annex)	6 months
Secondary	Quality of life	Diabetes Quality of Life Questionnaire (DQoL).	6 months
Secondary	Stress: DDS questionnaire	Diabetes Distress Scale (DDS) (Polonski et al, 2005)	6 months
Secondary	Time invested in the care of each patient	Costs and consumption of health resources: Time invested in the care of each patient in minutes	6 months
Secondary	Number of telephone calls	Costs and consumption of health resources: Number of telephone calls	6 months
Secondary	Number of face-to-face visits	Costs and consumption of health resources: Number of face-to-face visits	6 months
Secondary	Analytics performed in the center	Costs and consumption of health resources: Analytics performed in the center	6 months
Secondary	Analytic done in domestic scope with glucometer	Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer	6 months
Secondary	Cost of hypoglycaemic treatment (insulin)	Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.	6 months
Secondary	Costs and consumption of health resources	Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations	6 months
Secondary	Costs associated with the time spent going to the patient's hospital and family members	Costs and consumption of health resources: costs associated with the time spent going to the patient's hospital and family members	6 months
Secondary	Costs associated with days lost due to complications.	Costs and consumption of health resources: costs associated with days lost due to complications.	6 months
Secondary	Mean blood glucose	Glycemic control: Mean blood glucose (mg / dL)	6 months
Secondary	Standard deviation	Glycemic control: Standard deviation.	6 months