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Diabetes Mellitus, Type 1NCT04269668

An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Glycemic Control Using Hybrid-closed Loop vs. Advanced Hybrid Closed-loop in Young Subjects With Type 1 Diabetes

A study testing Medtronic Minimed 670G 3.0 HCL and Medtronic Minimed 670G 4.0 AHCL in people with Diabetes Mellitus, Type 1, run by Rabin Medical Center at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving quality of life. Read more about this study

Who is it for?
Ages 7 to 14 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Medtronic Minimed 670G 3.0 HCL and Medtronic Minimed 670G 4.0 AHCL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesin 2 countries
Study dates
19 Jul 2020to 20 Mar 2021
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 7 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diabetes type 1 duration >1 year since diagnosis
  • Pump therapy for at least 3 months and experience with sensor use
  • Age >=7 years up to 14 years
  • A1C>7.5% and <10.0%
  • BMI SDS below the 95th percentile for age
  • Subjects who live with at least one other adult person, who will be trained in managing an emergent hypoglycemia and who is able to contact the study subject any time
  • Subjects/caregivers capable of operating a computer-based system

Who cannot join

  • Subject is unable to tolerate tape adhesive in the area of sensor placement
  • Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
  • Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks
  • Subject has a positive pregnancy screening test
  • Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception or breast feeding women
  • Subject has had hypoglycemia resulting in loss of consciousness with or without seizure within the past 6 months prior to screening visit
Show all 29Show fewer
  • Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
  • Subject has a history of a seizure disorder
  • Subject has central nervous system or cardiac disorder resulting in syncope
  • Subject has eating disorder
  • Subjects with a history of adrenal insufficiency or chronic renal diseases
  • Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
  • Any disease or condition that may influence the A1C testing e.g. abnormal red blood cell indices and iron deficiency, sickle cell disease, hemoglobinopathy
  • Subject needs to travel by air during the study duration
  • Medication influencing coagulation as Marcumar or systemic Xa-Antagonists -Untreated coeliac disease (Transglutaminase in the last 6 months elevated 2x>upper limit)
  • Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders, schizophrenia)
  • Coagulation disorder, wound healing disorder
  • Severe diseases as cancer, heart failure, M. Parkinson, M. Addison, hyper or hypothyroidism, diabetic nephropathy or neuropathy or cardiomyopathy
  • Patients with Diabetes mellitus Type 2
  • Patients not willing to perform at least 4 blood glucose measurements a day.
  • Patients with a need of less than 8 IUE or more than 250 IUE a day.
  • Patients who are not willing to or not able to stay in contact with their physician.
  • Patient abusing illicit drugs, prescription drugs or alcohol
  • Patient is using other (other than insulin) diabetic medication incl. pramlintide (Symlin) DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors).
  • Patient or caregiver are expected to be incompliant with study procedures or instructions (e.g. sensor change, using the bolus wizard, falsifying carbohydrate intake) or are unlikely to understand study procedures or instructions.
  • Patient takes any oral, injectable, or IV steroids (incl. glucocorticoids).
  • Patients whose health or safety would be compromised by study participation according to the investigator's judgement.
  • Patient is taking any medication that is a contraindication for study participation according to the discretion of the investigator.
  • Patients who may have a risk not to realize acoustic or visual alarms due to visual or hearing impairment.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Diabetes -Zentrum fuer kinder und jugendliche

    Hanover

Other trials in Germany

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 4920235

Other trials in Israel

About this study

Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving quality of life. While overnight control is close to optimal under closed loop control, postprandial hyperglycemia during daytime remains a challenge. The advanced hybrid closed loop system was designed with an improved auto-basal control and additional auto-bolus module that delivers correction boluses automatically. In addition, this system was developed to improve user experience by significantly reducing the amount of alarms and exits from Auto Mode. Therefore, this system might have an advance in treating hyperglycemia over the hybrid closed loop that controls glucose levels by modulation of insulin basal rate only. Therefore, we propose the current study that will compare 6 weeks glycemic control using hybrid closed loop versus advanced hybrid closed loop that add correction boluses among young children and adolescents.

The objective of this study is to evaluate and compare the safety and efficacy of 6 weeks glucose control using Hybrid Closed Loop (HCL-670G) compared to Advanced Hybrid Closed Loop System (AHCL- 670G) in young subjects with sub-optimally controlled type 1 diabetes. A total of 28 subjects (age 7-14 years) will be enrolled at two investigational centers.

At the end of the cross-over study participants will be offered with an extension period, during which they will be offered to use their preferred closed-loop system for another 3 months

Being tested
Medtronic Minimed 670G 3.0 HCL, Medtronic Minimed 670G 4.0 AHCL
Keywords
Hybrid Closed Loop, Closed Loop, Artificial Pancreas
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Minimed 670G 3.0 HCLDevice

    Hybrid closed loop system

  • Medtronic Minimed 670G 4.0 AHCLDevice

    Advanced hybrid closed loop system

Study groups in NCT04269668
Study groupRoleWhat they receive
Medtronic Minimed 670G 3.0 HCLActive comparatorHybrid closed loop system
Receives: Device: Medtronic Minimed 670G 3.0 HCL
Medtronic Minimed 670G 4.0 AHCLExperimentalAdvanced hybrid closed loop system
Receives: Device: Medtronic Minimed 670G 4.0 AHCL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time of glucose sensor readings within 70 to 180 mg/dl

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  2. Percentage of time of glucose sensor readings below 54 mg/dl

    Measured: 6 weeks for each arm of the crossover

Secondary outcomes (14)

  1. Percentage of time of glucose levels spent below 70 mg/dl

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  2. Percentage of time of glucose levels spent above 180 mg/dl

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  3. Average glucose sensor readings

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  4. Standard deviation of glucose sensor readings

    Measured: 6 week for each arm of the crossover, day 90 of the extension period

  5. Fasting blood glucose levels

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  6. HbA1c change

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  7. Amount of total insulin delivery

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  8. Amount of basal insulin delivery

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  9. Amount of bolus insulin delivery

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  10. Serious Adverse Events (SAE)

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  11. Serious Adverse Device Events (SADE)

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  12. Unanticipated Adverse Device effects (UADE)

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  13. Incidence of Severe Hypoglycemia

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

  14. incidence of DKA

    Measured: 6 weeks for each arm of the crossover, day 90 of the extension period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start19 Jul 2020
  3. Primary completion20 Feb 2021
  4. Study completion20 Mar 2021

Resources

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
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269668
Sponsor's protocol ID
RMC077719ctil
Status last verified
Feb 2021
First submitted
6 Feb 2020
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Minimed 670G 3.0 HCL and Medtronic Minimed 670G 4.0 AHCL in people with Diabetes Mellitus, Type 1, run by Rabin Medical Center at 2 sites in 2 countries.

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 7 inclusion and 29 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: finished, as of the sponsor's last update on 22 Feb 2022. 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 Germany, Israel. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time of glucose sensor readings within 70 to 180 mg/dl (time frame: 6 weeks for each arm of the crossover, day 90 of the extension period). The study lists 2 primary outcomes in all. 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 NCT04269668.

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 22 Feb 2022.

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