N/A
Completed N=29
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Diabetes Type 2
Source: ClinicalTrials.gov NCT04233229 ↗
Enrolled (actual)
29
Serious AEs
24.1%
Results posted
Apr 2025
Primary outcomePrimary: Time in Range (TIR) — 36.61; 63.03 percentage of time — p=<.001
Summary
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.
A wide acceptance of the Artificial Pancreas (AP) usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice.
The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored Home Healthcare Provider (HHP) service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled T2D needing home nursing care for their daily insulin treatment versus usual care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range (TIR) |
36.61; 63.03 | <.001 sig |
| SECONDARY Time in Range (TIR) During Diurnal Period |
37.48; 34.30; 36.96; 60.19 | <.001 sig |
| SECONDARY Time in Range (TIR) During Nocturnal Period |
43.20; 34.82; 35.56; 71.56 | <.001 sig |
| SECONDARY Time Above Range (TAR) (Above 180 mg/dL) |
60.43; 64.59; 62.69; 36.14 | <.001 sig |
| SECONDARY Time Above Range (TAR) (Above 250 mg/dL) |
30.21; 31.76; 28.50; 9.12 | 0.003 sig |
| SECONDARY Time Below Range (TBR) (Below 70 mg/dL) |
0.65; 0.98; 0.70; 0.83 | 0.79 |
| SECONDARY Time Below Range (TBR) (Below 54 mg/dL) |
0.14; 0.59; 0.17; 0.18 | 0.84 |
| SECONDARY Glucose Variability (% CV Coefficient of Variation) |
28.22; 29.45; 28.22; 31.51 | 0.060 |
| SECONDARY HbA1c |
9.16; 9.03; 8.79; 7.42 | <.001 sig |
| SECONDARY Total Daily Insulin Dose |
80.3; 66.8; 111.7; 80.6 | 0.52 |
| SECONDARY Body Weight |
92.10; 86.05; 91.34; 87.66 | 0.08 |
Eligibility Criteria
Selection criteria:
- 1. Male or female patient aged 18 years or older, 2. Type 2 Diabetes diagnosed for at least 6 months with a stable authorized antidiabetic therapeutic regimen for 3 months, 3. Treated with insulin for at least 6 months, 4. Patient with 8.0% ≤ HbA1c 4,
- Patient who has disabilities which could compromise the compliance to the study, in the investigator's opinion,
- Patient with severe health impairment resulting in short life expectancy (< 1 year) as assessed by the investigator,
- Patient participating in another interventional or observational clinical trial or who participated in another interventional clinical trial within 30 days before selection,
- Patient known allergy to any component of the automated insulin delivery system compounds,
- Proliferative retinopathy (assessed with a fundus examination or retinal photography performed within 6 months before selection or before the randomisation at the latest) with visual impairment which could compromise the safety of rapid glucose control normalisation and the compliance to the study,
- Planned initiation of a treatment that would impact the blood glucose levels (such as steroids) during the study period,
- Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation.
- Lack of effective contraception in women of childbearing potential,
- Subject with a history of hearing or vision impairment hindering perception of glucose display and alarms (as this point is a contra-indication stated in the user's manual of the investigational medical device),
- Severe impairment of renal function (Creatinine Clearance < 30 mL/min),
- Patient on dialysis (as the user's manual of Dexcom G6 states that G6 readings may be inaccurate in this population)
- Conditions which may increase the risk of induced hypoglycemia as per the investigator's judgment,
- lnpatient psychiatric treatment in the past 6 months,
- Current or recent abuse of alcohol or recreational drugs,
- Patients that have frequent exposure to magnetic resonance imaging (MRl), computed tomography (CT) scan, or high frequency electrical heat (diathermy) treatment (as this point is a contra-indication stated in the user's manual of the investigational medical device and Dexcom G6
Data sourced from ClinicalTrials.gov (NCT04233229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.