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Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections 260 Observationnel

Inconnu
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04013919 est une étude observationnel pour Diabète sucré. Son statut actuel est : inconnu. L'étude a débuté le 20 septembre 2019 et vise à recruter 260 participants. Dirigée par DreaMed Diabetes, l'étude devrait être terminée d'ici le 1 avril 2020. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 26 décembre 2019.
Résumé succinct
This is an observational, multicenter prospective study including up to 260 subjects with type 1 or type 2 diabetes who use insulin injections (either basal insulin only or multiple daily injections (MDI)) and CGM or SMBG to manage their diabetes. The study aims to generate the database needed for future development and verification of insulin-glucose modules of subjects with diabetes using insulin injections.

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Titre officiel

Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose

Pathologies
Diabète sucré
Autres identifiants de l'étude
  • CR-0999
Numéro NCT
NCT04013919
Date de début (réel)
2019-09-20
Dernière mise à jour publiée
2019-12-26
Date de fin (estimée)
2020-04
Inscription (estimée)
260
Type d'étude
Observationnel
Statut
Inconnu
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Type 1 Diabetes
Multiple Daily Injections of Insulin
Basal/ Bolus insulin injections
Type 2 Diabetes
Multiple Daily Injections of Insulin
Basal/ Bolus insulin injections
Single insulin injections
Basal insulin injections only
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Glucose levels
Characterise the insulin-glucose dynamics for insulin users
1 month
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
1 Year
Sexes éligibles
Tous

  1. Documented T1D or T2D for at least 1 year prior to study enrolment

  2. T1D: Subjects aged 1 year or older

  3. T2D: Subjects aged 30 years or older

  4. A1c at inclusion ≤ 10%

  5. Subjects using basal-bolus MDI therapy or basal insulin only - basal insulin Lantus or Tregludec and any short acting insulin.

    • T2D: Insulin pumps will also be accepted.

  6. T2D: BMI ≥ 25 kg/m2

  7. Subjects willing to follow study instructions:

    1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile. Document blood glucose level, insulin delivery, meals and daily activities. Optional: wear blinded CGM.
    2. For CGM users: Document insulin delivery, meals and daily activities. Optional:

    Measure capillary blood glucose in addition.

  8. Adult subjects or parents of pediatric subjects willing and able to sign a written informed consent form.

  1. An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
  2. Concomitant diseases/ treatment that influence metabolic control (except diabetes treatment for T2) or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise subject's safety
  3. T2D: eGFR < 60
  4. Participation in any other interventional study
  5. Female subject who is pregnant or planning to become pregnant within the planned study duration
  6. T1D: Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
  7. Drug or alcohol abuse.
DreaMed Diabetes logoDreaMed Diabetes
Contact central de l'étude
Contact: Yael Shtrit, 0502428305, [email protected]
1 Centres de l'étude dans 1 pays
Scheider MC, Petah Tikva, 4952805, Israel
Orna Harmon, Contact, 972-3-9253618, [email protected]
En recrutement