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Continuous Glucose Monitor in Children With Poorly Controlled Diabetes 30

Abgeschlossen
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT02530450 untersuchte Typ-1-Diabetes mellitus als beobachtungsstudie und hat den Status abgeschlossen. Die Studie begann am 1. Mai 2011 mit 30 Teilnehmern. Sie wurde durchgeführt von The University of Texas Health Science Center at San Antonio und am 1. März 2013 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. Oktober 2017 aktualisiert.
Kurzbeschreibung
The purpose of this study is to determine if the use of continuous glucose monitoring in a practical outpatient clinic setting in children with poorly controlled diabetes will lead to improved blood sugar control.
Ausführliche Beschreibung
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the Univer...Mehr anzeigen
Offizieller Titel

iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study

Erkrankungen
Typ-1-Diabetes mellitus
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • HSC20110049H
NCT-Nummer
NCT02530450
Studienbeginn (tatsächlich)
2011-05
Zuletzt aktualisiert
2017-10-06
Studienende (vorauss.)
2013-03
Geplante Rekrutierung
30
Studientyp
Beobachtungsstudie
Status
Abgeschlossen
Stichwörter
children
poor adherence
continuous glucose monitoring
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Group 1
Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM)
All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
Group 2
Never blinded to continuous glucose monitoring (CGM) data
continuous glucose monitoring (CGM)
All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The Primary Outcome Measure Was Change in HgbA1c
0 months, 3 months and 6 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia
3 months and 6 months
Eignungskriterien

Zugelassene Altersgruppen
Kind
Mindestalter
7 Years
Zugelassene Geschlechter
Alle
  1. Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
  2. Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
  3. HgbA1c >8.5% (equivalent to average BG of >205 mg/dL for past three months).
  4. Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
  5. Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
  6. Attend proposed clinic, nutritional, and CGM follow up visits.
  7. Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
  8. Hypoglycemic unawareness.
  9. English or Spanish primary language.

  1. Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
  2. Documented concomitant chronic disease known to affect glycemic control.
  3. 3 or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
  4. 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
  5. Reported alcohol or drug abuse.
  6. Documented cutaneous allergy to latex products.
  7. Documented eating disorders or morbid obesity as assessed by the investigator.
  8. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
  9. Home use of CGM in the past 6 months.
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