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TelemedicinePLATEDIANNCT03332472

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

A study testing Telemedicine group and Conventional group in people with Telemedicine, run by Sociedad Andaluza de Endocrinología, Diabetes y Nutrición at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Telemedicine
What is being tested?
Telemedicine group and Conventional group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
1 siteSpain
Study dates
Dec 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Regional Universitario de Málaga. Unidad de Diabetes

    Málaga, 29010

Other trials in Spain

About this study

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

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.

Read the detailed 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:

  1. 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.
  2. Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).
  3. Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.
  4. Costs and consumption of health resources:

-Cost-effectiveness (HbA1C)

Conditions
Telemedicine
Being tested
Telemedicine group, Conventional group
Keywords
type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine groupOther

  • Conventional groupOther

Study groups in NCT03332472
Study groupRoleWhat they receive
Telemedicine groupExperimentalTelematics visit in front of the conventional visit face to face
Receives: Other: Telemedicine group
Conventional groupPlacebo comparatorGroup with conventional medical visit
Receives: Other: Conventional group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Glycosylated hemoglobin

    Measured: 6 months

Secondary outcomes (21)

  1. Total daily dose of insulin

    total daily doseof insulin (IU/day)

    Measured: 6 months

  2. Total daily dose of insulin by weight

    Total daily dose by weight (IU / kg / day)

    Measured: 6 months

  3. Number of mild hypoglycaemia

    Acude complications prior to V1: number of mild hypoglycaemia

    Measured: 6 months

  4. Number of severe hypoglycemia

    Acute complications prior to V1: number of severe hypoglycemia

    Measured: 6 months

  5. Number of hyperglycemia greater than 250 mg / dl / week

    Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week

    Measured: 6 months

  6. 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

    Measured: 6 months

  7. Number of hospital admissions due to glycemic decompensations

    Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.

    Measured: 6 months

  8. Fear of hypoglycemia: FH-15 scale

    Hypoglycemia Fear test: FH-15 questionnaire (Annex)

    Measured: 6 months

  9. Quality of life

    Diabetes Quality of Life Questionnaire (DQoL).

    Measured: 6 months

  10. Stress: DDS questionnaire

    Diabetes Distress Scale (DDS) (Polonski et al, 2005)

    Measured: 6 months

  11. Time invested in the care of each patient

    Costs and consumption of health resources: Time invested in the care of each patient in minutes

    Measured: 6 months

  12. Number of telephone calls

    Costs and consumption of health resources: Number of telephone calls

    Measured: 6 months

  13. Number of face-to-face visits

    Costs and consumption of health resources: Number of face-to-face visits

    Measured: 6 months

  14. Analytics performed in the center

    Costs and consumption of health resources: Analytics performed in the center

    Measured: 6 months

  15. Analytic done in domestic scope with glucometer

    Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer

    Measured: 6 months

  16. Cost of hypoglycaemic treatment (insulin)

    Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.

    Measured: 6 months

  17. Costs and consumption of health resources

    Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations

    Measured: 6 months

  18. 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

    Measured: 6 months

  19. Costs associated with days lost due to complications.

    Costs and consumption of health resources: costs associated with days lost due to complications.

    Measured: 6 months

  20. Mean blood glucose

    Glycemic control: Mean blood glucose (mg / dL)

    Measured: 6 months

  21. Standard deviation

    Glycemic control: Standard deviation.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study startDec 2013
  3. Primary completionNov 2014
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332472
Sponsor's protocol ID
PLATEDIAN
Acronym
PLATEDIAN
Status last verified
Nov 2017
First submitted
24 Jul 2017
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1016/s0022-3476(94)70190-3.

    PubMed 8040759

  • American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.

    PubMed 22187469

  • 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. doi: 10.2337/diacare.26.5.1475.

    PubMed 12716807

  • 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.

    PubMed 11187566

  • 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.

    PubMed 21266648

  • 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.

    PubMed 21889388

  • 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. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.

    PubMed 17395516

  • Gomez EJ, Hernando ME, Garcia A, Del Pozo F, Cermeno J, Corcoy R, Brugues 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. doi: 10.1016/s0169-2607(02)00039-1.

    PubMed 12100795

  • Rigla M, Hernando ME, Gomez EJ, Brugues E, Garcia-Saez 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. doi: 10.1177/193229680700100408.

    PubMed 19885113

  • 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. doi: 10.1016/s0169-2607(02)00038-x.

    PubMed 12100794

  • 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. doi: 10.2337/diacare.28.11.2697.

    PubMed 16249542

  • Jansa 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. doi: 10.1016/j.diabres.2006.03.005. Epub 2006 Apr 18.

    PubMed 16621113

  • 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. doi: 10.2337/diacare.27.5.1088.

    PubMed 15111526

  • 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.

    PubMed 19808926

  • Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS, Rondan RM, Carreira M, Dominguez-Lopez M, Machado A, Gonzalo-Marin M, Tapia MJ, Valdes S, Gonzalez-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.

    PubMed 21381839

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine group and Conventional group in people with Telemedicine, run by Sociedad Andaluza de Endocrinología, Diabetes y Nutrición at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332472, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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