ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes

NCT ID: NCT04235504

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2022-05-30

Brief Summary

The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.

Detailed Description

This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period:

1. Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks.

2. Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm.

3. Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system.

Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

The Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0

Group Type: ACTIVE_COMPARATOR

MDI

Intervention Type: OTHER

Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM

AHCL

Intervention Type: DEVICE

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.

Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.

Treatment Arm

The Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase.

Group Type: EXPERIMENTAL

AHCL

Intervention Type: DEVICE

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.

Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.

Interventions

MDI

Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM

Intervention Type: OTHER

AHCL

Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.

Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is age ≥ 18 years old at time of screening

2. Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation

3. On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening

4. Subject has been followed and treated by the investigator at this investigational site for at least 3 months prior to screening and subject has already undergone local educational therapeutic programs.

5. Subject is using:

• Flash Glucose Monitoring (FGM) for ≥ 3 months with a daily average number of scans ≥ 5 over and with sensor readings > 70% of time over the previous month prior to screening (based on sensor usage from the download summary report of the FGM system over 30 days prior to screening) Or
• Continuous Glucose Monitoring (CGM) for ≥ 3 months with a frequency of sensor use ≥ 70% of the time over the previous month prior to screening (based on download summary report from the CGM system over 30 days prior to screening).

6. Subject has a glycosylated hemoglobin (HbA1c) ≥ 8.0% (64 mmol/mol) at time of screening visit (as processed by a Central Lab).

7. Subject is willing to take or switch to one of the following insulins:

1. Humalog™ (insulin lispro injection)

2. NovoLog™ (insulin aspart)

8. Subject must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 8 units and a maximum of 250 units.

9. Subject is willing to upload data from the study pump and meter, must have Internet access and a compatible computer system that meets the requirements for uploading the study pump data at home.

10. Subject is willing and able to sign and date informed consent, comply with all study procedures and wear all study devices, as required during the study.

Exclusion Criteria

1. Subject has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.

2. Subject is using pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors at time of screening.

3. Subject has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 12 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.

4. Subject is planning to switch from FGM to CGM therapy during the 6 months study phase. Note: Subject randomized to Control Arm should remain on their current FGM or CGM therapy during the study phase and will be switched to AHCL during the continuation phase.

5. Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.

6. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.

7. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study, per investigator judgment.

8. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

9. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.

10. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.

11. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

12. Subject is legally incompetent, illiterate or vulnerable person.

13. Research staff involved with the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

Besançon, , France

CHU de Bordeaux - Hôpital Saint André

Bordeaux, , France

CHU Caen

Caen, , France

Hospices Civils de Lyon (DIAB-e CARE)

Lyon, , France

APM - Hôpital de la Conception

Marseille, , France

Hospital Civil

Strasbourg, , France

Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa

Bergheim, , Germany

Zentrum für Diabetologie Bergedorf

Hamburg, , Germany

Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis

Lage, , Germany

Medical Center am Clemenshospital Dr. Winfried Keuthage

Münster, , Germany

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, , United Kingdom

Harrogate and District Hospital - NHS Foundation Trust

Harrogate, , United Kingdom

University Hospitals of Leicester NHS Trust Leicester General Hospital

Leicester, , United Kingdom

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Countries

France; Germany; United Kingdom

References

Jendle J, Buompensiere MI, Ozdemir Saltik AZ, de Portu S, Smith-Palmer J, Pollock RF, Cohen O. A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2023 Dec;25(12):864-876. doi: 10.1089/dia.2023.0297.

Reference Type: DERIVED

PMID: 37801658 (View on PubMed)

Edd SN, Castaneda J, Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, Cellot J, de Portu S, Vorrink L, Shin J, van den Heuvel T, Cohen O; ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2023 Nov;25(11):3212-3222. doi: 10.1111/dom.15217. Epub 2023 Aug 8.

Reference Type: DERIVED

PMID: 37551542 (View on PubMed)

Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1.

Reference Type: DERIVED

PMID: 36058207 (View on PubMed)

de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.

Reference Type: DERIVED

PMID: 35110310 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Study Phase

View Document

Document Type: Statistical Analysis Plan: Continuation Phase

View Document

Other Identifiers

CIP327

Identifier Type: -

Identifier Source: org_study_id