DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump Trial

NCT05628532 | Completed DMC

• 1 other identifier: RCB 2022-A01901-42
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief Summary

This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62. After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system. The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes. Data related to their glycemia, complications, usability and quality of life will be collected. The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

Conditions

Diabetes Mellitus, Type 1

Keywords

regulation algorithm; Diabetes Treatment; Closed loop

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in 70 - 180 mg/dL glycemic range

  Impact of the use of DBLG1 system on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage.

  56 days

Secondary Outcomes (17)

• Percentage of time spent in specific glycemic ranges

  98 days

• Incidence of severe hypoglycemia

  98 days

• Incidence of severe hyperglycemia

  98 days

• Number of adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated serious adverse device effects

  98 days

• Evolution of HbA1c measured by blood sampling for patients participating in extension study phase

  98 days

Study Arms (1)

Use of the DBLG1 system

EXPERIMENTAL

After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period with the DBLG1 system followed by an optional 42-day extension period.

Device: Use of the DBLG1 system

Interventions

Use of the DBLG1 system DEVICE

During the treatment period, the patient will use the DBLG1 system (consisting of a DBLG1 handset with an embedded software named loop mode, a TERUMO MEDISAFE WITH patch pump and a Dexcom continuous glucose monitoring (CGM) G6). The main function of DBLG1 System is to adjust the insulin delivery at the correct time in order to maintain the patient's blood glucose in the target range and thus minimize both hypoglycaemic events and long-term complications associated with elevated average glycemia.

Use of the DBLG1 system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who is at least 18 years old,
• The total daily dose required must be less than 90 units (U),
• Subject accepting to be treated with 100 U/mL rapid-acting insulin analog,
• HbA1c ≤ 10%,
• Subject must be affiliated to any kind of social security,
• Living in an area covered by a GSM (Global System for Mobile Communications) network,
• Non-isolated patient, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home,
• Must be able to speak and be literate in French,
• Having signed the free and informed consent form

You may not qualify if:

• Subject receiving a total daily dose of insulin below 8 U,
• Subject suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids),
• Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity,
• Subject unable to understand and perform instructions provided by Diabeloop SA,
• Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period,
• Subject who is unwilling or unable to maintain contact with the healthcare professional,
• Subject using a pacemaker. There is the risk of this device adversely affecting pacemakers and causing them to malfunction,
• Subject is unable to tolerate tape adhesive around the sensor or pump placements,
• Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection),
• Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks,
• Subject is using DPP-4 inhibitor, GLP-1 agonists, metformin, α-glucosidase inhibitors, thiazolidinediones and/or other SGLT2 inhibitors at time of screening,
• Diagnosed with chronic kidney disease (glomerular filtration \< 30 mL/min or Serum creatinine \> 176 µmol/L),
• Patient who has had a pancreatectomy or who has pancreatic malfunctions or pancreatic islet transplantation or pancreas transplantation,
• Patient on dialysis,
• Patient with impaired hepatic functions,

Sponsors & Collaborators

• Diabeloop: lead
• Icadom: collaborator

Study Sites (10)

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Groupe Hospitalier La Rochelle - Ré - Aunis

La Rochelle, 17019, France

Location

CHU Lille - Hôpital Huriez

Lille, 59037, France

Location

Centre du diabète DIAB-eCARE - HCL

Lyon, 69008, France

Location

Hôpital la Conception - APHM

Marseille, 13005, France

Location

Hôpital Nord Laennec

Nantes, 44093, France

Location

CHU Rennes Pontchaillou

Rennes, 35000, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67000, France

Location

CHU Toulouse - Hôpital de Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alfred PENFORNIS, Pr

  CH Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional single-arm open-label before/after multicentric national study

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: February 3, 2023
• Primary Completion: February 21, 2024
• Study Completion: April 29, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

FR (10)