Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia

NCT04266379 | Unknown DMC FDA Device

• 4 other identifiers: RECHMPL19_0351-(7826)2019-A01906-51CIV-FR-19-12-031026UC4DK108483
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Keywords

Type 1 diabetes; Hypoglycemia; Closed-loop insulin infusion

Outcome Measures

Primary Outcomes (1)

• Difference in percent of time spent with blood glucose level below 70 mg/dL

  Baseline-treatment difference in % of time spent with blood glucose level below 70 mg/dL over the 3 months follow-up

  3 months

Secondary Outcomes (24)

• Percent of time within target range 70-180 mg/dL

  3 months

• Percent of time spent with blood glucose level above 180 mg/dL

  3 months

• Mean blood glucose level

  3 months

• Percent of time spent with blood glucose level below 54 mg/dL

  3 months

• Percent of time spent with blood glucose in range 70-140 mg/dL

  3 months

Study Arms (2)

Closed-Loop Control (CLC)

EXPERIMENTAL

Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm

Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions

Sensor Augmented Pump (SAP)

ACTIVE COMPARATOR

Closed-loop subcutaneous insulin infusion and continuous glucose monitoring manage by patient

Device: Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring

Interventions

Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions DEVICE

Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data

Also known as: Artificial Pancreas

Closed-Loop Control (CLC)

Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring DEVICE

Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor

Also known as: Sensor Augmented Pump, CSII and CGM

Sensor Augmented Pump (SAP)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• Use of an insulin pump for at least 6 months
• Age ≥18 .0 years old
• HbA1c level \<10.5% at screening
• Clarke score \>3 and/or experience of severe hypoglycemia during the previous 6 months
• For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial
• Willingness to establish network connectivity on at least a weekly basis
• Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog). Patients using glulisine (Apidra) may switch to lispro or aspart at least one month prior to enrollment.
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
• Subject is covered by social health or similar insurance
• Informed consent form signed

You may not qualify if:

• Use of SGLT2 inhibitors in the 3 months prior to enrollment
• Hemophilia or any other bleeding disorder
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Employed by, or having immediate family members employed by Tandem or Dexcom
• Persons deprived of freedom, protected by law or vulnerable persons
• Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
• Impaired renal function (Creatinine Clearance \< 30 ml/min)
• Patient who had pancreas transplantation or pancreatic islet transplantation
• Patient having severe problems of uncorrected hearing and/or visual acuity
• Subjects with known allergy to CGM adhesives
• Patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment
• Patient without any social or familial support able to intervene in case of severe hypoglycemic episode

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Virginia: collaborator

Study Sites (2)

University Hospital of Caen

Caen, France

ACTIVE NOT RECRUITING

UH Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• Renard E, Joubert M, Villard O, Dreves B, Reznik Y, Farret A, Place J, Breton MD, Kovatchev BP; iDCL Trial Research Group. Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial. Diabetes Care. 2023 Dec 1;46(12):2180-2187. doi: 10.2337/dc23-0685.

  PMID: 37729080 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Pancreas, Artificial; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Eric M RENARD, MD, PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M RENARD, MD, PhD

CONTACT

+33 467 338 382; e-renard@chu-montpellier.fr

Jerome PLACE, MSc

CONTACT

+33 467 457 310; jerome.place@umontpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 12, 2020
• Study Start: May 13, 2020
• Primary Completion: November 3, 2022
• Study Completion: February 3, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

FR (2)