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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)
Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age ≥ 18 et < 70 years old
- Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
- Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
- BMI < 35 kg/m²
- Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
- Trained in carbohydrate counting
- HbA1c > 7.5 % and < 10%
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
- Willing to undergo all study procedures
- Informed consent signed
Exclusion criteria:
- Pregnancy or breast feeding, or intention to be pregnant during the study duration
- Use of a medication that significantly impacts glucose metabolism, e.g. steroids
- Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
- Patient plans to go abroad during the trial period
- Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
- Patient does not hold any nearby party for assistance if needed
- Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
- Presence of any malignant disease, unless considered as cured for more than 10 years
- History of acute cardiovascular event during the prior year
- History of diabetic keto-acidosis during the prior 6 months
- Renal insufficiency with creatinin > 150 μmol/L
- Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
- Impaired cognitive or psychological abilities which may result in defective adherence to study conditions
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: HYBRID-OPEN
Patients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes. |
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
|
Experimenteel: OPEN-HYBRID
Patients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes. |
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period
Tijdsspanne: during 2 months-hybrid period and during 2 months-open period
|
during 2 months-hybrid period and during 2 months-open period
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Low Blood Glucose Index (LBGI)
Tijdsspanne: for each period of 2 month (hybrid period and open period)
|
for each period of 2 month (hybrid period and open period)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Eric ER RENARD, MD, University Hospital, Montpellier
Publicaties en nuttige links
Algemene publicaties
- Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.
- Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 8628 4
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