- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00831389
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)
9 november 2017 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06519
- Yale Pediatrics Diabetes Research
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 30 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Closed Loop (CL) Phase
|
Insulin pump controlled by closed loop unit and algorithm
|
Inget ingripande: Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Plasma Glucose (PG) Response to Exercise
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Peak Post-prandial Plasma Glucose (PG)
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Stuart Weinzimer, MD, Yale University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2009
Primärt slutförande (Faktisk)
1 november 2010
Avslutad studie (Faktisk)
1 november 2010
Studieregistreringsdatum
Först inskickad
26 januari 2009
Först inskickad som uppfyllde QC-kriterierna
26 januari 2009
Första postat (Uppskatta)
28 januari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ePID-03
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Typ 1-diabetes mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Diabetes typ 1 | Typ 1-diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinberoende | Ungdomsdiabetes | Diabetes, autoimmun | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | Diabetes mellitus, spröd | Diabetes mellitus, juvenil-debut och andra villkorFörenta staterna
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAvslutadTyp 1-diabetes mellitus | Diabetes mellitus, typ I | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | IDDMFörenta staterna, Australien
-
Capillary Biomedical, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Typ 1-diabetes mellitus | Diabetes mellitus, insulinberoende, 1Australien
-
SanofiAvslutadTyp 1-diabetes mellitus-typ 2-diabetes mellitusUngern, Ryska Federationen, Tyskland, Polen, Japan, Förenta staterna, Finland
-
Hanmi Pharmaceutical Company LimitedOkändTyp 2 diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCAvslutadTyp 2-diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AvslutadTyp 1-diabetes mellitus | T1DM | T1D | Nyuppkommen typ 1-diabetes mellitusFörenta staterna, Australien
-
Spiden AGDCB Research AGRekryteringTyp 1-diabetes mellitus | Typ 1-diabetes mellitus med hypoglykemi | Typ 1-diabetes mellitus med hyperglykemiSchweiz
-
Shanghai Changzheng HospitalRekryteringSpröd typ 1-diabetes mellitusKina
-
Capillary Biomedical, Inc.AvslutadTyp 1-diabetes | Typ 1-diabetes mellitus | Diabetes mellitus, typ I | Diabetes mellitus, insulinberoende, 1 | IDDMÖsterrike
Kliniska prövningar på Closed Loop
-
Azienda Ospedaliera Cardinale G. PanicoAvslutadSynkope, Vasovagal, neuralt medieradItalien
-
University of PennsylvaniaRekrytering
-
Biotronik SE & Co. KGAvslutad
-
Duke UniversityAvslutadNeuropatisk smärtaFörenta staterna
-
University of CambridgeCambridge University Hospitals NHS Foundation TrustAvslutadStörningar i glukosmetabolism | Autoimmuna sjukdomar | Diabetes mellitus | Sjukdomar i det endokrina systemet | Diabetes mellitus, typ 1Storbritannien
-
Centre Hospitalier Sud FrancilienRekryteringDiabetes typ 1 | Tonåringar | Unga vuxnaFrankrike
-
Cardiff and Vale University Health BoardAvslutad
-
Prasad Shirvalkar, MD, PhDNational Institute of Neurological Disorders and Stroke (NINDS); United...Aktiv, inte rekryterandeKronisk smärta | Ryggmärgsskador | Fantomsmärta i lem | Smärta efter strokeFörenta staterna
-
Stanford UniversityRekryteringParkinsons sjukdomFörenta staterna
-
Massachusetts General HospitalHar inte rekryterat ännuSchizofreniFörenta staterna