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

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Recruiting

CT.gov ID

NCT05282264

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

12.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Other: device

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Acceptability of hybrid closed-loop systems [at 12 months]
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

Secondary Outcome Measures

Demographic characteristics : age [at day 0]
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
Demographic characteristics : gender [at day 0]
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
Demographic characteristics : level of education [at day 0]
year
Demographic characteristics : currrent activity [at day 0]
student, active, retired, unemployed, etc.
Demographic characteristics : duration of diabete [at day 0]
year
HbA1c [at day 0]
HbA1c
Efficiency [At baseline, 3, 6, and 12 months]
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).
Quality [At baseline, 3, 6, and 12 months]
Questionnaire Diabetes Quality of life : from 1 ( very satisfaying) to 5 (very unsatisfactory)
Patient satisfaction [At baseline, 3, 6, and 12 months]
Questionnaire Diabetes Quality of life : from 3 (many) to -3 (less)
Hypoglycemia Fear [At baseline, 3, 6, and 12 months]
Hypoglycemia Fear Survey : from 0 (never) to 4 (almost always)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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…)