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Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)

9 novembre 2017 aggiornato da: Medtronic Diabetes
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise. Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

13

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06519
        • Yale Pediatrics Diabetes Research

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 30 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male and female subjects between 12-30 years of age.
  • Subjects must weigh at least 50 kg to accommodate phlebotomy.
  • Previously diagnosed Type 1 Diabetes Mellitus
  • Diabetes duration at least 1 year.
  • Currently treating their diabetes with an insulin pump.
  • A1C of ≤ 9.0 % at time of enrollment.
  • Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
  • Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
  • Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
  • Able to tolerate a 75-minute exercise period of moderate intensity.
  • Speak and understand English.
  • Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.

Exclusion Criteria:

  • Pregnancy (urine pregnancy test) or lactation, if female.
  • Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
  • Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.

  • Subject using any of the following medications:

    • glucocorticoids
    • cyclosporine
    • L-asparaginase
    • niacin
    • protease inhibitors
    • anti-psychotics
    • GnRH agonists
    • beta-blockers
    • calcium channel blockers
    • immunosuppressants
    • over-the-counter medications that may effect glucose metabolism.

  • Subject has any of the following conditions

    • insulin allergy
    • severe insulin resistance
    • exercise-induced asthma
    • musculoskeletal problems that may impact ability to complete exercise protocol
    • substance abuse
    • skin ulcers or poor wound healing
    • bleeding disorders
    • chronic infections
    • eating disorders
    • give a history of or are predisposed to major stress
    • any other major organ system disease.
  • Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
  • Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
  • Subjects using dietary supplements within 14 days of study enrollment
  • Subject is currently enrolled in another study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Closed Loop (CL) Phase
Dispositivo: Closed Loop
Insulin pump controlled by closed loop unit and algorithm
Nessun intervento: Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma Glucose (PG) Response to Exercise
Lasso di tempo: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
PG at start of exercise minus the subsequent PG nadir
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Incidence of Hypoglycemia Immediately Following Exercise
Lasso di tempo: Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
Incidence of Nocturnal Hypoglycemia Following Exercise
Lasso di tempo: Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.
Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak Post-prandial Plasma Glucose (PG)
Lasso di tempo: Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
Nadir Plasma Glucose (PG) Immediately Following Exercise
Lasso di tempo: Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
The PG nadir observed following the start of exercise
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
Overnight Nadir Plasma Glucose (PG)
Lasso di tempo: Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
Lasso di tempo: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
Lasso di tempo: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
Lasso di tempo: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medtronic Diabetes

Collaboratori

Juvenile Diabetes Research Foundation

Investigatori

  • Investigatore principale: Stuart Weinzimer, MD, Yale University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2009

Completamento primario (Effettivo)

1 novembre 2010

Completamento dello studio (Effettivo)

1 novembre 2010

Date di iscrizione allo studio

Primo inviato

26 gennaio 2009

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2009

Primo Inserito (Stima)

28 gennaio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ePID-03

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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