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Insulin Pump Versus Full Closed-loop for Type 2 Diabetes

NCT06959797 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-07

No results posted yet for this study

Summary

The aim of the study is to compare, in a population of patients with type 2 diabetes, open-loop insulin pump treatment with the CamAPS HX (Camdiab) Fully Closed Loop Automated Insulin Therapy system, on the efficacy and safety of use of the Fully Closed Loop, as well as on psycho-social criteria of device acceptability, quality of life and diabetes burden. This is an open, multi-center, randomized, cross-over study, based on several observational or controlled trials carried out in Cambridge by Prof. Hovorka's team (see paragraph 4 below). The study will comprise a run-in phase followed by a 1st sequence in which randomized patients will use the Ypsomed pump (Ypsomed) and the FreeStyle Libre 3 sensor in open loop for 12 weeks Versus the Ypsomed pump (Ypsomed) coupled with the CamAPS HX algorithm and the FreeStyle Libre 3 sensor in full closed loop. At the end of this 1ère sequence, all patients will undergo a 2-4 week washout, during which they will use the Ypsomed pump and the FreeStyle Libre 3 sensor in open loop, and then in the 2nd sequence of the study, patients will switch to the other treatment for a further 12 weeks. A total of 80 patients on insulin pumps for at least 6 months will be recruited from 9 French centers. All patients will receive training in the use of the Ypsomed pump, the FreeStyle Libre 3 sensor and the CamAPS HX algorithm. The primary objective is Time on Target 70-180 mg/dl of 24h measured during the 12 weeks of each therapeutic period. Secondary objectives will be Time in Target 70-180 mg/dl day and night, Time above Target \> 180 mg/dl and \> 250 mg/dl, Time below Target \< 70 mg/dl and \< 54 mg/dl, time in the narrow target range 70-140 mg/dL, mean 24h blood glucose and glycemic variability measured over the 12 weeks of each treatment sequence, HbA1c, weight, total insulin dose and psychosocial endpoints assessed at the start and end of each treatment sequence. Safety data studied will include diabetes-related adverse events (ketoacidosis, symptomatic and severe hypoglycemia) and medical device-related adverse events (pump and sensor).

Conditions

Interventions

DEVICE

Closed loop

Ypsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott)

DEVICE

Open loop

Ypsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott)

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Ypsomed Diabetes Care AG

    collaborator INDUSTRY

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959797 on ClinicalTrials.gov