Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients. A wide acceptance of the Artificial Pancreas (AP) usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice. The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored Home Healthcare Provider (HHP) service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled T2D needing home nursing care for their daily insulin treatment versus usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
43
closed-loop in patients at home for three months
home healthcare services from Air Liquide in patients at home for three months
multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring
CHRU Brest
Brest, Brittany Region, France
CHU Rouen
Rouen, Normandy, France
CHU Amiens
Amiens, Picardie, France
CHU Caen
Caen, France
Hopital Européen de Marseille
Marseille, France
CHU Nantes
Nantes, France
CHU Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
CHRU Nancy-Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
APHP Lariboisière
Paris, Île-de-France Region, France
Time in Range (TIR)
Time In Range, defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording from days 70 to 90
Time frame: From days 70 to 90
Time in Range (TIR) During Diurnal Period
Time in range during diurnal period (06.00-23.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Time in Range (TIR) During Nocturnal Period
Time in range during nocturnal period (00.00-05.59), defined as the percentage of time spent with glucose measurements at 70-180 mg/dL (3.9-10.0 mmol/L) recorded by continuous glucose monitoring (CGM), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 180 mg/dL)
Time above target range defined as the percentage of time spent with CGM glucose measurements \>180 mg/dL (10.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Time Above Range (TAR) (Above 250 mg/dL)
Time above target range defined as the percentage of time spent with CGM glucose measurements ≥250 mg/dL (13.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 70 mg/dL)
Time below target range, defined as the percentage of time spent with CGM glucose measurements \<70 mg/dL (3.9 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Time Below Range (TBR) (Below 54 mg/dL)
Time below target range, defined as the percentage of time spent with CGM glucose measurements \<54 mg/dL (3.0 mmol/L), during the last 14 days completed CGM recording at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
Glucose Variability (% CV Coefficient of Variation)
Glucose variability assessed by coefficient of glucose variation (% CV) calculated by dividing the Standard Deviation (SD) by the corresponding mean of the CGM glucose measurements during the last 14 days at the end of the selection period (baseline before randomisation) and the last 14 days from days 70 to 90
Time frame: At baseline and From days 70 to 90
HbA1c
Blood glycated Haemoglobin A1c (HbA1c) value assayed in % at initiation visit (day 0) and at day 90
Time frame: On day 0 and day 90
Total Daily Insulin Dose
Total daily insulin dose (expressed in IU/day) calculated as the sum of daily dose of insulin injections recorded by investigators whether basal, bolus or premix at selection (baseline) and study end (planned on day 90) visits
Time frame: At selection (baseline) and study end (day 90) visits
Body Weight
Body weight (expressed in kg) recorded by investigators at initiation (day 0) and study end (planned on day 90) visits
Time frame: At initiation (day 0) and study end (day 90) visits
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