Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia
NCT ID: NCT04266379
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2020-05-13
2023-02-03
Brief Summary
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Detailed Description
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The CLC system will consist of Tandem Control-IQ Automated Insulin Delivery System (AIDS), including Tandem X2 insulin pump with embedded Control-IQ algorithm and Dexcom G6 CGM
After consent is signed, eligibility will be assessed. All participants will initiate a run-in phase of 2 weeks of blinded Dexcom G6 CGM wear and personal insulin pump.
Prior to overall initiation of the RCT, the time spent with CGM below 70 mg/dl during the run-in phase will be assessed. Only patients showing % time with CGM \<70 mg/dl of 5% or above can be randomized. Included patients who cannot be randomized will be replaced.
Subsequent participants who show randomization criteria during the run-in phase 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Closed-Loop Control (CLC)
Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm
Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Sensor Augmented Pump (SAP)
Closed-loop subcutaneous insulin infusion and continuous glucose monitoring manage by patient
Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring
Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor
Interventions
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Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring
Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Use of an insulin pump for at least 6 months
3. Age ≥18 .0 years old
4. HbA1c level \<10.5% at screening
5. Clarke score \>3 and/or experience of severe hypoglycemia during the previous 6 months
6. 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.
7. Willingness not to use glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study. This does not concern treatment with Metformin active and stable for more than 3 months prior the inclusion. Moreover, the use of SGLT2 inhibitors is not allowed in the 3 months prior to enrollment.
8. Willingness to suspend use of any personal CGM for the duration of the clinical trial
9. Willingness to establish network connectivity on at least a weekly basis
10. 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.
11. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
12. Subject is covered by social health or similar insurance
13. Informed consent form signed
Exclusion Criteria
2. Hemophilia or any other bleeding disorder
3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
5. Employed by, or having immediate family members employed by Tandem or Dexcom
6. Persons deprived of freedom, protected by law or vulnerable persons
7. Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
8. Impaired renal function (Creatinine Clearance \< 30 ml/min)
9. Patient who had pancreas transplantation or pancreatic islet transplantation
10. Patient having severe problems of uncorrected hearing and/or visual acuity
11. Subjects with known allergy to CGM adhesives
12. Patients that have frequent exposure to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment
13. Patient without any social or familial support able to intervene in case of severe hypoglycemic episode
18 Years
ALL
No
Sponsors
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Tandem Diabetes Care, Inc.
INDUSTRY
DexCom, Inc.
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Virginia
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Eric M RENARD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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University Hospital of Caen
Caen, , France
UH Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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ERIC RENARD, MD
Role: primary
References
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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.
Other Identifiers
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2019-A01906-51
Identifier Type: REGISTRY
Identifier Source: secondary_id
CIV-FR-19-12-031026
Identifier Type: REGISTRY
Identifier Source: secondary_id
RECHMPL19_0351-(7826)
Identifier Type: -
Identifier Source: org_study_id