REMOTE-T1DRole of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
iBGStar meter
Maladies Auto-immunes+5
+ Diabète Mellitus
+ Maladies du système endocrinien
Étude sur les services de santé
Résumé
Date de début de l'étude : 1 décembre 2012
Date à laquelle le premier participant a commencé l'étude.This is a single-center, prospective, randomized, 'open-label,' investigator initiated pilot study evaluating the role of mobile technology to improve diabetes care in adults with type 1 diabetes (REMOTE-T1D). We hypothesize that the use of mobile technology (iBGStar® technology [iPhone® plus the BGStar®]) will result in improvement in Patient Reported Outcomes (PRO), and Treatment Satisfactions with a possible reductions of glucose excursions, A1c, and severe hypoglycemia as compared to routine clinical care using traditional glucose meter SMBG-Accu-chek®. This study aims to demonstrate the efficacy of these technologies in a clinical setting with a hope to improve outcomes and health care cost savings. The study will enroll 100 patients from the Barbara Davis Center Adult clinic over the age of 18 years who will be randomized in a 1:1 fashion to intervention group using mobile technology (iBG Star) vs. continued routine clinical care (control) using SMBG-Accu-chek meter. All subjects will be followed for study visits with similar frequency at baseline, 1-week, 1-month, 3-months, and 6-months and wear a continuous glucose monitor (CGM) using a DexCom SEVEN Plus® system in a blinded mode for 7 days at baseline (wk0), 1mo, 3mo, and 6mo. Laboratory analysis for A1c will be performed at baseline, 1-month 3-months, and 6-months. Routine blood tests will be performed in all subjects at baseline, 3months, and 6-months. Blinded CGM data will be analyzed for mean blood glucose values, time spent in hyperglycemic (>240, >300mg/dl) and hypoglycemic (<50, <70, <80 mg/dl) ranges and various indices of glycemic variability.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Recherche sur les services de santé
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Subjects that meet the following criteria will be considered for admission to the study: Signed informed consent before any study-related activities Male or female aged 18 years and older T1D duration >1 year A1c <10% Willingness to routinely practice at least 3-7 blood glucose measurements per day Ability and willingness to adhere to the protocol including scheduled study visits and blinded CGM wear intermittently) for 6 months. During the weeks of blinded CGM wear, subjects will not be able to use their own real-time CGMs (if they own it) Able to speak, read and write English Exclusion Criteria: Subjects will be excluded from the study if any of the following apply: Pregnant or intention to become pregnant during the course of the study Severe unexplained hypoglycemia requiring emergency treatment in the previous 6 months Use of systemic or inhaled corticosteroids History of hemoglobinopathies Diagnosis of anemia History of pancreatitis Extensive skin changes/diseases that inhibit wearing a sensor on normal skin Known allergy to adhesives Current participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to enrollment. Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent Subjects will not be allowed to use real-time CGM during the blinded CGM wear week.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Pas d'interventionGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site