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

Type 1 Diabetes Clinical Trial

— HCL-VHP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282264
• Other study ID #: IDRCB 2022-A00144-39
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 11, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• device
closed-loop insulin

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex
France	Penfornis	Corbeil-essonnes Cedex	Centre Hospitalier Sud Francilien

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Demographic characteristics : level of education	year	at day 0
Secondary	Demographic characteristics : currrent activity	student, active, retired, unemployed, etc.	at day 0
Secondary	Demographic characteristics : duration of diabete	year	at day 0
Secondary	HbA1c	HbA1c	at day 0
Secondary	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
Secondary	Quality	Questionnaire Diabetes Quality of life : from 1 ( very satisfaying) to 5 (very unsatisfactory)	At baseline, 3, 6, and 12 months
Secondary	Patient satisfaction	Questionnaire Diabetes Quality of life : from 3 (many) to -3 (less)	At baseline, 3, 6, and 12 months
Secondary	Hypoglycemia Fear	Hypoglycemia Fear Survey : from 0 (never) to 4 (almost always)	At baseline, 3, 6, and 12 months