NCT03332472

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

July 24, 2017

Last Update Submit

November 1, 2017

Conditions

Telemedicine

Keywords

type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycosylated hemoglobin

    6 months

Secondary Outcomes (21)

  • Total daily dose of insulin

    6 months

  • Total daily dose of insulin by weight

    6 months

  • Number of mild hypoglycaemia

    6 months

  • Number of severe hypoglycemia

    6 months

  • Number of hyperglycemia greater than 250 mg / dl / week

    6 months

  • +16 more secondary outcomes

Study Arms (2)

Telemedicine group

EXPERIMENTAL

Telematics visit in front of the conventional visit face to face

Other: Telemedicine group

Conventional group

PLACEBO COMPARATOR

Group with conventional medical visit

Other: Conventional group

Interventions

Telemedicine groupOTHER
Telemedicine group
Conventional groupOTHER
Conventional group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with DM1 over 2 years of evolution.
  • Age ≥18 and \<65 years.
  • Intensive insulin therapy with basal-bolus MDI.
  • Patients living in Andalusian
  • Patients candidates for telemonitoring.
  • Patients who have received written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional Universitario de Málaga. Unidad de Diabetes

Málaga, 29010, Spain

Location

Related Publications (16)

  • 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.

    PMID: 8040759BACKGROUND

  • 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.

    PMID: 22187469BACKGROUND

  • 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.

    PMID: 12716807BACKGROUND

  • 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.

    PMID: 11187566BACKGROUND

  • 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.

    PMID: 21266648BACKGROUND

  • 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.

    PMID: 21889388BACKGROUND

  • 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.

    PMID: 17395516BACKGROUND

  • 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.

    PMID: 12100795BACKGROUND

  • 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.

    PMID: 19885113BACKGROUND

  • 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.

    PMID: 12100794BACKGROUND

  • 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.

    PMID: 16249542BACKGROUND

  • 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.

    PMID: 16621113BACKGROUND

  • 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.

    PMID: 15111526BACKGROUND

  • 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.

    PMID: 19808926BACKGROUND

  • 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.

    PMID: 21381839BACKGROUND

  • Ruiz de Adana MS, Alhambra-Exposito MR, Munoz-Garach A, Gonzalez-Molero I, Colomo N, Torres-Barea I, Aguilar-Diosdado M, Carral F, Serrano M, Martinez-Brocca MA, Duran A, Palomares R; Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition). Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study. Diabetes Care. 2020 Feb;43(2):337-342. doi: 10.2337/dc19-0739. Epub 2019 Dec 12.

    PMID: 31831473DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

November 6, 2017

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)