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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Centre hospitalier Sud Francilien
  • Centre Hospitalier Sud Francilien
    • Corbeil-Essonnes, Centre Hospitalier Sud Francilien, France, 91106
      • Penfornis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients followed in the diabetes department of the Centre Hospitalier Sud Francilien

Description

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…)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with hybrid closed-loop systems	Other: device; closed-loop insulin
Patient without hybrid closed-loop systems

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Publications and helpful links

General Publications

• Deepchand S, Balla V, Eroukhmanoff J, Ly Sall K, Romain B, Lejeune M, Penfornis A, Amadou C. Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe! Diabetes Technol Ther. 2024 Feb;26(2):125-129. doi: 10.1089/dia.2023.0379. Epub 2024 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; efficacy and safety; acceptability; Highly unbalanced Type 1 diabetes; hybrid closed loops
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Equipment and Supplies
• Other Study ID Numbers: 2022-A00144-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No