Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes

Study Overview
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Brief Summary
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While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes. The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c>11% in the past 12 months and a mean HbA1c >10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.

Detailed Description
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If hybrid closed-loop systems (HCLS) (artificial pancreas) for automated insulin administration have demonstrated their great interest in patients living with moderately unbalanced type 1 diabetes (T1D) (HbA1c < 8 .6% on average), no study has looked at their safety, acceptability and efficacy in patients living with highly and chronically unbalanced T1D (HbA1c > 11%). These patients, often young, present more or less advanced microangiopathic complications (retinopathy, nephropathy, neuropathy, etc.) or are highly exposed to the appearance of these complications, the prevention of which, whether primary or secondary, involves obtaining a good glycemic balance over time. These patients escape the possibilities of current insulin therapy, whether by multiple insulin injections or by insulin pump, more or less coupled to a continuous glucose monitoring system. Automated insulin delivery systems could be a solution to achieve less catastrophic glycemic control in some of these patients. The investigators are proposing a pilot study aimed at evaluating acceptability, safety and effectiveness of a HCLS currently available in France (the SMARTGUARD™ MINIMED™ 780G or the Control-IQ) in patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien (CHSF), living with highly unbalanced T1D (HbA1c > 11%) in the context of usual follow-up.

Official Title
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Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with closed loop system : Adult patients With T1D for at least 2 years Follow-up in the diabetes department of the CHSF Having a laboratory HbA1c > 11% at least once during the past year and at least one other HbA1c > 10% in the previous 3 years Accepting the closed loop system as part of their support Subject informed of the study and not objecting to it Patients without closed loop system : Adult patients With T1D for at least 2 years Follow-up in the diabetes department of the CHSF Having a laboratory HbA1c > 11% at least once during the past year and at least one other HbA1c > 10% in the previous 3 years Refusing the closed loop system as part of their support or Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and nurse referents of the patient) within the service leads to the evaluation of an unfavorable benefit/risk ratio Subject informed of the study and not objecting to it Exclusion Criteria: Patients with closed loop system : Patients without an Internet connection, or without a smartphone or computer Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and patient referent nurse) within the department results in the assessment of an unfavorable benefit/risk ratio (patients with a history of interrupted pump treatment on medical decision, serious psychiatric disorders…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with hybrid closed-loop systems<br> | Other: device<br>* closed-loop insulin<br>|
| Patient without hybrid closed-loop systems<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of hybrid closed-loop systems | Maintenance rate of a hybrid closed-loop system in patients living with highly unbalanced T1D (HbA1c > 11%) and followed in the diabetes department of the CHSF | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics : age | year lives alone or not; precariousness index, psychiatric history, number of hospitalizations related to diabetes, severe hypoglycaemia, ketoacidosis in the last 3 years, weight, body mass index (BMI), treatment of diabetes: pump (brand, year), multiple injections (MDI), complications of diabetes; microangiopathic: retinopathy (shape and stage), nephropathy (estimated glomerular filtration rate by the CKD-EPI formula, albuminuria/creatinine ratio), neuropathies; macroangiopathic average HbA1c level for the last 3 years | at day 0 | 
| Demographic characteristics : gender | feminine or masculine psychiatric history, number of hospitalizations related to diabetes, severe hypoglycaemia, ketoacidosis in the last 3 years, weight, body mass index (BMI), treatment of diabetes: pump (brand, year), multiple injections (MDI), complications of diabetes; microangiopathic: retinopathy (shape and stage), nephropathy (estimated glomerular filtration rate by the CKD-EPI formula, albuminuria/creatinine ratio), neuropathies; macroangiopathic average HbA1c level for the last 3 years | at day 0 | 
| Demographic characteristics : level of education | year | at day 0 | 
| Demographic characteristics : currrent activity | student, active, retired, unemployed, etc. | at day 0 | 
| Demographic characteristics : duration of diabete | year | at day 0 | 
| HbA1c | HbA1c | at day 0 | 
| Efficiency | If the patient has interrupted the treatment with hybrid closed-loop, reason for the discontinuation, % of time spent under HCLS, Change of pump between M0 and M12 (Yes/no). Change of transmitter between M0 and M12 (Yes/no), Average total insulin dose per day, Basal/Bolus ratio, Amount of carbohydrates entered/day, Target objective (mg/dL) set, Number of sensors consumed Number of sensor malfunctions International consensus criteria on the interpretation of continuous glucose monitoring (CGM): Evolution of the time spent in the target (TIR), Change in time above target (TAR) for hyperglycaemia > 250 mg/dL, from 181 to 250 mg/dL, Evolution of the time spent below the target of 54 to 69 mg/dL and < 54 mg/dL, Evolution of the glycemic average, Evolution of the coefficient of variation (CV). | At baseline, 3, 6, and 12 months | 
| Quality | Questionnaire Diabetes Quality of life : from 1 ( very satisfaying) to 5 (very unsatisfactory) | At baseline, 3, 6, and 12 months | 
| Patient satisfaction | Questionnaire Diabetes Quality of life : from 3 (many) to -3 (less) | At baseline, 3, 6, and 12 months | 
| Hypoglycemia Fear | Hypoglycemia Fear Survey : from 0 (never) to 4 (almost always) | At baseline, 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Highly unbalanced Type 1 diabetes, hybrid closed loops, acceptability, efficacy and safety, quality of life