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Type 1 DiabetesNCT04761094

Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain

An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 25 sites 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

Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Type 1 Diabetes
What is being tested?
Insulin pump
How many people
2,977 participants
Where
25 sitesSpain
Study dates
1 Sep 2021to 31 Dec 2021
How long will I take part?
9 Months
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.

Who may be able to join

  • Type 1 diabetes patients treated with insulin pump.
  • Medical treatment received in Spain.

Who cannot join

  • Any other kinds of diabetes.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Spain25 sites

  • Badajoz University Hospital

    Badajoz, 06080

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Obispo Rafael Torija, St.

    Ciudad Real, 13005

  • Hospital San Joan de Deu

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario de Jerez

    Jerez de la Frontera, Cadiz, 11407

  • Centro Medico D-Medical

    Madrid, 28001

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Clinica DiaLibre

    Madrid, 28702

  • Hospital Universitario Carlos Haya

    Málaga, Malaga, 29010

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29010

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28703

  • Hospital Universitario de Santiago de Compostela

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41013

  • Hospital Universitario Joan XXIII

    Tarragona, 43005

  • Hospital Universitario Mutua de Tarrasa

    Terrassa, Barcelona, 08221

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

About this study

Official title: Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain

Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.

Read the detailed description

Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.

All clinical variables are gathered from the Spanish Insulin Pump National Registry.

Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Conditions
Type 1 Diabetes
Being tested
Insulin pump
Keywords
Type 1 diabetes, Treatment, Insulin pump, Continuous subcutaneous insulin infusion
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.

  • Insulin pumpDevice

    Treatment with continuous subcutaneous insulin infusion

Study groups in NCT04761094
Study groupRoleWhat they receive
Insulin pumpAll patient treated with insulin pump.
Receives: Device: Insulin pump

What is being measured

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

  1. HbA1C

    Glycated haemoglobin A1C

    Measured: During the procedure

Secondary outcomes (12)

  1. TIR

    Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose

    Measured: During the procedure

  2. TAR

    Time above range (TAR, >10 mmol/L, >180 mg/dL) of the interstitial glucose

    Measured: During the procedure

  3. TUR

    Time under range (TUR, <3.9 mmol/L, <70 mg/dL) of the interstitial glucose

    Measured: During the procedure

  4. Clinical significant hypoglycemia

    Time in clinical significant hypoglycemia (< 3 mmol/L, <54 mg/dL) of the interstitial glucose

    Measured: During the procedure

  5. MIG

    Mean interstitial glucose (mmol/L, mg/dL)

    Measured: During the procedure

  6. %CV

    Percentage of the variation coefficient (%, >36% is considered high levels)

    Measured: During the procedure

  7. Adherence to CGM

    Time of use of continuous glucose monitoring (% possible time of use)

    Measured: During the procedure

  8. Weight

    Total corporal weight (Kg)

    Measured: During the procedure

  9. Insulin dose

    Daily insulin dose requirements (UI/Kg/d)

    Measured: During the procedure

  10. DKA

    Number of diabetic ketoacidosis (number of events)

    Measured: During the procedure

  11. Severe hypoglycemia

    Number of severe hypoglycemia (number of events)

    Measured: During the procedure

  12. Hospital admission

    Number of hospital admission due to insulin pump (number of events)

    Measured: During the procedure

Timeline

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

  1. First posted18 Feb 2021
  2. Study start1 Sep 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,977 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04761094
Sponsor's protocol ID
C-386
Status last verified
Feb 2022
First submitted
12 Feb 2021
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: IPD will be available after studying each request.

Publications

  • Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.

    PubMed 3517648

  • 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

  • Yeh HC, Brown TT, Maruthur N, Ranasinghe P, Berger Z, Suh YD, Wilson LM, Haberl EB, Brick J, Bass EB, Golden SH. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med. 2012 Sep 4;157(5):336-47. doi: 10.7326/0003-4819-157-5-201209040-00508.

    PubMed 22777524

  • Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.

    PubMed 23039989

  • Beato-Vibora P, Chico-Ballesteros A, Gimenez M, Guerrero-Vazquez R, Barrio-Castellanos R, Goni-Iriarte MJ, Diaz-Soto G, Merino-Torres JF, Moreno-Fernandez J, Martinez-Brocca MA; Diabetes Technology Working Group of the Spanish Diabetes Association. A national survey on the efficacy and safety of continuous subcutaneous insulin infusion in patients with type 1 diabetes in Spain. Diabetes Res Clin Pract. 2018 Mar;137:56-63. doi: 10.1016/j.diabres.2017.12.009. Epub 2017 Dec 24.

    PubMed 29278712

  • Moreno-Fernandez J, Gomez FJ, Pines P, Gonzalez J, Lopez J, Lopez LM, Blanco B, Roa C, Herranz S, Munoz-Rodriguez JR. Continuous Subcutaneous Insulin Infusion in Adult Type 1 Diabetes Mellitus Patients: Results from a Public Health System. Diabetes Technol Ther. 2019 Aug;21(8):440-447. doi: 10.1089/dia.2019.0097. Epub 2019 Jun 13.

    PubMed 31199682

  • Moreno-Fernandez J, Chico A, Martinez-Brocca MA, Beato-Vibora PI, Vidal M, Piedra M, Quiros C, Munoz-Rodriguez JR; SPAIP Registry Study. Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry. Diabetes Technol Ther. 2022 Dec;24(12):898-906. doi: 10.1089/dia.2022.0207. Epub 2022 Sep 6.

    PubMed 35947087

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 25 sites 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 2 inclusion and 1 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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. 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: During the procedure). 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 NCT04761094, which also lists 7 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 9 Feb 2022.

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