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MD Logic Pump Advisor- Adults Study

10 gennaio 2017 aggiornato da: Rabin Medical Center

Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study

Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).

The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.

The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.

The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).

Endpoints:

  • Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
  • Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.

Inclusion Criteria:

  • Subject with Type 1 diabetes (>1yr since diagnosis)
  • Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
  • Age ≥ 18 years
  • HbA1c at inclusion ≥ 6.0%
  • No concomitant diseases that influence metabolic control
  • No current use of CGM
  • Subjects do not participate in any other interventional study

Tipo di studio

Interventistico

Iscrizione (Effettivo)

18

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

  • Israele
      • Petaach-Tikva, Israele, 49202
        • Schneider Children's Medical Center
  • Slovenia
      • Ljubljana, Slovenia
        • University Children's Hospital

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 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Subject with Type 1 diabetes (>1yr since diagnosis)
  2. Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
  3. Age ≥ 18 years
  4. HbA1c at inclusion ≥ 6.0%
  5. No concomitant diseases that influence metabolic control
  6. No current use of CGM
  7. Subjects do not participate in any other interventional study

Exclusion Criteria:

  1. Known or suspected allergy to trial products.
  2. Any significant diseases or 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 patient safety
  3. Subject is currently using CGM device
  4. Diabetic ketoacidosis in the past 3 months.
  5. Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
  6. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  7. Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
  8. Female subject who is pregnant or planning to become pregnant within the planned study duration

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: intervantion group
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.
Dispositivo: MD Logic Pump Advisor
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
Nessun intervento: control group
Regular treatment, No change will be made in the insulin pump setting during the study(unless there is a medical need or any safety concern).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time spent in the normal range
Lasso di tempo: during each 6 days iteration
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
during each 6 days iteration

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Lasso di tempo: Day 78
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Day 78
time spent above 180 mg/dl
Lasso di tempo: during each 6 days iteration
time spent above 180 mg/dl
during each 6 days iteration
time spent below 70 mg/dl
Lasso di tempo: during each 6 days iteration
time spent below 70 mg/dl
during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
Lasso di tempo: during each 6 days iteration
Number of Hypoglycemic events below 63 mg/dl
during each 6 days iteration
Adverse event
Lasso di tempo: during each 6 days iteration
Adverse event
during each 6 days iteration
glucose variability- area under the curve
Lasso di tempo: during each 6 days iteration
glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl
during each 6 days iteration
Quality of Life Questionaires
Lasso di tempo: At the end of the study- day 30 -78
Quality of Life Questionaires
At the end of the study- day 30 -78
Number of MDLAP-recommendations that were rejected by the physician
Lasso di tempo: during each 6 days iteration
Number of MDLAP-recommendations that were rejected by the physician
during each 6 days iteration
Number and type of changes in any pump setting per iteration
Lasso di tempo: during each 6 days iteration
Number and type of changes in any pump setting per iteration
during each 6 days iteration

Collaboratori e investigatori

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

Sponsor

Rabin Medical Center

Collaboratori

Medtronic

Investigatori

  • Investigatore principale: Moshe Phillip, Prof, Schenider Children's Medical

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 luglio 2010

Completamento primario (Effettivo)

1 luglio 2016

Completamento dello studio (Effettivo)

1 luglio 2016

Date di iscrizione allo studio

Primo inviato

27 giugno 2010

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2010

Primo Inserito (Stima)

7 luglio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 gennaio 2017

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • rmc005816ctil

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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