Trials / Completed
CompletedNCT04233229
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes Patients (T2D)
Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Air Liquide Santé International · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | t:slim X2 with Control-IQ | closed-loop in patients at home for three months |
| OTHER | home healthcare services | home healthcare services from Air Liquide in patients at home for three months |
| OTHER | usual care for daily insulin treatment | multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring |
Timeline
- Start date
- 2019-12-30
- Primary completion
- 2022-05-30
- Completion
- 2022-05-30
- First posted
- 2020-01-18
- Last updated
- 2025-04-20
- Results posted
- 2025-04-20
Locations
10 sites across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04233229. Inclusion in this directory is not an endorsement.