This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.
This study is randomized controlled trial of 3 month at home closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase. The objective is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes prone to hypoglycemia. The CLC system will consist of Tandem Control-IQ Automated Insulin Delivery System (AIDS), including Tandem X2 insulin pump with embedded Control-IQ algorithm and Dexcom G6 CGM After consent is signed, eligibility will be assessed. All participants will initiate a run-in phase of 2 weeks of blinded Dexcom G6 CGM wear and personal insulin pump. Prior to overall initiation of the RCT, the time spent with CGM below 70 mg/dl during the run-in phase will be assessed. Only patients showing % time with CGM \<70 mg/dl of 5% or above can be randomized. Included patients who cannot be randomized will be replaced. Subsequent participants who show randomization criteria during the run-in phase will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor
University Hospital of Caen
Caen, France
ACTIVE_NOT_RECRUITINGUH Montpellier
Montpellier, France
RECRUITINGDifference in percent of time spent with blood glucose level below 70 mg/dL
Baseline-treatment difference in % of time spent with blood glucose level below 70 mg/dL over the 3 months follow-up
Time frame: 3 months
Percent of time within target range 70-180 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose level above 180 mg/dL
Time frame: 3 months
Mean blood glucose level
Time frame: 3 months
Percent of time spent with blood glucose level below 54 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose in range 70-140 mg/dL
Time frame: 3 months
Glucose variability measured with the coefficient of variation (CV)
Time frame: 3 months
Glucose variability measured with the standard deviation (SD)
Time frame: 3 months
Percent of time spent with blood glucose level below 60 mg/dL
Time frame: 3 months
Low blood glucose index (LBGI)
\<2.5 low risk , \[2.5-5\] medium risk, \>5 high risk
Time frame: 3 months
Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg/dL)
Time frame: 3 months
Percent of time spent with blood glucose level above 250 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose level above 300 mg/dL
Time frame: 3 months
High blood glucose index (HBGI)
\<2.5 low risk , \[2.5-5\] medium risk, \>5 high risk
Time frame: 3 months
HbA1c at 3 months
Time frame: at 3 months
HbA1c change from baseline to 3 months
Time frame: 3 months
Fear of Hypoglycemia Survey
Total score from 0 (no fear) to 132 (important fear)
Time frame: 3 months
Hyperglycemia Avoidance Scale
Total score from 0 (do not avoid) to 40 (always avoid)
Time frame: 3 months
Diabetes Distress Scale
Total score range from 28 (low stress) to 168 (high stress)
Time frame: 3 months
Hypoglycemia Confidence Scale
Total score from 0 (no confidence) to 36 (very confident)
Time frame: 3 months
Clarke Hypoglycemia Awareness
Score range from 0 to 7. If more than 4 : reduced perception, if less : normal perception.
Time frame: 3 months
INSPIRE survey
Total score from 0 (high acceptance) to 110 (low acceptance)
Time frame: 3 months
System Usability Scale (SUS)
Total score from 0 (low acceptance) to 100 (high acceptance)
Time frame: 3 months
Insulin
Total daily insulin (units/kg), Basal: bolus insulin ratio
Time frame: 3 months
Weight and Body Mass Index (BMI)
Time frame: 3 months
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