Type 1 Diabetes Mellitus With HypoglycemiaDCLP2NCT04266379
Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia
A study testing Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions and Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hypoglycemia
- What is being tested?
- Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions and Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 13 May 2020to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Active, not recruiting
University Hospital of Caen
Caen
- Recruiting
UH Montpellier
Montpellier, 34295
ERIC RENARD, MD, +33467338384, e-renard@chu-montpellier.fr
About this study
Official title: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia
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.
Read the detailed description
This study is randomized controlled trial of 3 month at home closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase. The objective is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes prone to hypoglycemia.
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.
- Being tested
- Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions, Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring
- Keywords
- Type 1 diabetes, Hypoglycemia, Closed-loop insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsDevice
Also called Artificial Pancreas
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
Continuous Subcutaneous Insulin Infusion and Continuous Glucose MonitoringDevice
Also called Sensor Augmented Pump, CSII and CGM
Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop Control (CLC) | Experimental | Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm Receives: 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 Receives: Device: Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (24)
Percent of time within target range 70-180 mg/dL
Measured: 3 months
Percent of time spent with blood glucose level above 180 mg/dL
Measured: 3 months
Mean blood glucose level
Measured: 3 months
Percent of time spent with blood glucose level below 54 mg/dL
Measured: 3 months
Percent of time spent with blood glucose in range 70-140 mg/dL
Measured: 3 months
Glucose variability measured with the coefficient of variation (CV)
Measured: 3 months
Glucose variability measured with the standard deviation (SD)
Measured: 3 months
Percent of time spent with blood glucose level below 60 mg/dL
Measured: 3 months
Low blood glucose index (LBGI)
<2.5 low risk , [2.5-5] medium risk, >5 high risk
Measured: 3 months
Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg/dL)
Measured: 3 months
Percent of time spent with blood glucose level above 250 mg/dL
Measured: 3 months
Percent of time spent with blood glucose level above 300 mg/dL
Measured: 3 months
High blood glucose index (HBGI)
<2.5 low risk , [2.5-5] medium risk, >5 high risk
Measured: 3 months
HbA1c at 3 months
Measured: at 3 months
HbA1c change from baseline to 3 months
Measured: 3 months
Fear of Hypoglycemia Survey
Total score from 0 (no fear) to 132 (important fear)
Measured: 3 months
Hyperglycemia Avoidance Scale
Total score from 0 (do not avoid) to 40 (always avoid)
Measured: 3 months
Diabetes Distress Scale
Total score range from 28 (low stress) to 168 (high stress)
Measured: 3 months
Hypoglycemia Confidence Scale
Total score from 0 (no confidence) to 36 (very confident)
Measured: 3 months
Clarke Hypoglycemia Awareness
Score range from 0 to 7. If more than 4 : reduced perception, if less : normal perception.
Measured: 3 months
INSPIRE survey
Total score from 0 (high acceptance) to 110 (low acceptance)
Measured: 3 months
System Usability Scale (SUS)
Total score from 0 (low acceptance) to 100 (high acceptance)
Measured: 3 months
Insulin
Total daily insulin (units/kg), Basal: bolus insulin ratio
Measured: 3 months
Weight and Body Mass Index (BMI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start13 May 2020
- Primary completion3 Nov 2022 (estimated)
- Study completion3 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia
- Responsible party
- Sponsor
- Investigators
- Eric M RENARD, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266379
- Sponsor's protocol ID
- RECHMPL19_0351-(7826)
- Other IDs
- 2019-A01906-51, CIV-FR-19-12-031026, UC4DK108483
- Acronym
- DCLP2
- Status last verified
- Dec 2021
- First submitted
- 3 Feb 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Sharing with NIDDK
Publications
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.
PubMed 37729080
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia
- ClinicalTrials.gov ID
- NCT04266379
- Acronym / sponsor ID
- DCLP2 / RECHMPL19_0351-(7826)
- Keywords
- Type 1 diabetes, Hypoglycemia, Closed-loop insulin infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia
- Study start
- 13 May 2020 (actual)
- Primary completion
- 3 Nov 2022 (estimated)
- Study completion
- 3 Feb 2023 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is randomized controlled trial of 3 month at home closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase. The objective is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes prone to hypoglycemia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop Control (CLC) | Experimental | Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsClosed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm |
| Sensor Augmented Pump (SAP) | Active comparator | Device: Continuous Subcutaneous Insulin Infusion and Continuous Glucose MonitoringClosed-loop subcutaneous insulin infusion and continuous glucose monitoring manage by patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsAlso: Artificial PancreasContinuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data | Device | Closed-Loop Control (CLC) |
| Continuous Subcutaneous Insulin Infusion and Continuous Glucose MonitoringAlso: Sensor Augmented Pump, CSII and CGMInsulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor | Device | Sensor Augmented Pump (SAP) |
Primary outcome
Difference in percent of time spent with blood glucose level below 70 mg/dL
Time frame: 3 months
Baseline-treatment difference in % of time spent with blood glucose level below 70 mg/dL over the 3 months follow-up
24 secondary outcomes
Percent of time within target range 70-180 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose level above 180 mg/dL
Time frame: 3 months
Mean blood glucose level
Time frame: 3 months
Percent of time spent with blood glucose level below 54 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose in range 70-140 mg/dL
Time frame: 3 months
Glucose variability measured with the coefficient of variation (CV)
Time frame: 3 months
Glucose variability measured with the standard deviation (SD)
Time frame: 3 months
Percent of time spent with blood glucose level below 60 mg/dL
Time frame: 3 months
Low blood glucose index (LBGI)
Time frame: 3 months
Hypoglycemia events (defined as at least 15 consecutive minutes <70 mg/dL)
Time frame: 3 months
Percent of time spent with blood glucose level above 250 mg/dL
Time frame: 3 months
Percent of time spent with blood glucose level above 300 mg/dL
Time frame: 3 months
High blood glucose index (HBGI)
Time frame: 3 months
HbA1c at 3 months
Time frame: at 3 months
HbA1c change from baseline to 3 months
Time frame: 3 months
Fear of Hypoglycemia Survey
Time frame: 3 months
Hyperglycemia Avoidance Scale
Time frame: 3 months
Diabetes Distress Scale
Time frame: 3 months
Hypoglycemia Confidence Scale
Time frame: 3 months
Clarke Hypoglycemia Awareness
Time frame: 3 months
INSPIRE survey
Time frame: 3 months
System Usability Scale (SUS)
Time frame: 3 months
Insulin
Time frame: 3 months
Weight and Body Mass Index (BMI)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Derived from this study: PubMed 37729080Renard 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.
- Individual participant dataSharing planned: Yes. Sharing with NIDDK
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M RENARD, MD, PhD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions and Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric M RENARD, MD, PhD (+33 467 338 382, e-renard@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percent of time spent with blood glucose level below 70 mg/dL (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.