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Type 1 Diabetes Mellitus Prone to HypoglycemiaNCT05628662

Artificial Pancreas With Carbohydrate Suggestion for Patients With Type 1 Diabetes Prone to Hypoglycemia

A study testing Automated Insulin Delivery System (SAFE-AP) in people with Type 1 Diabetes Mellitus Prone to Hypoglycemia, run by Hospital Clinic of Barcelona at 1 site in Spain.

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

Achieving near-normoglycemia has been established as the main objective for most patients with Type 1 Diabetes (T1D). Automated insulin delivery (AID) systems, the so-called artificial pancreas (AP) or closed-loop systems, may represent the ideal solution, especially for patients not reaching the therapeutic goals… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Automated Insulin Delivery System (SAFE-AP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSpain
Study dates
22 Oct 2021to 6 Apr 2022
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

  • Subjects aged 18 or more with Type 1 Diabetes for at least 5 years.
  • Treated with continuous subcutaneous insulin infusion (CSII) for at least six months.
  • Trained to carbohydrate counting.
  • Subjects prone to hypoglycemia, despite optimal diabetes management and hypoglycemia-specific education programs, as defined by >4 hypoglycemic episodes per week and at least one of the following:
  • Occurrence of at least 2 severe hypoglycemic episodes during the last 2 years (need for third party).
  • Occurrence of at least 1 severe hypoglycemic episode during the last 2 years and high glycemic variability (coefficient of variation >36%).
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  • Impaired awareness of hypoglycemia (Clarke test ≥4).
  • Physical examination, laboratory data and EKG without alterations. Abnormalities considered clinically irrelevant by the investigator will not be exclusion criteria.
  • Negative SARS-CoV-2 PCR test performed at arrival.
  • Subject willing to wear the SAFE-AP system continuously throughout the study.

Who cannot join

  • Pregnancy and breastfeeding.
  • History of drug or alcohol abuse.
  • Progressive fatal disease.
  • Clinically relevant microvascular complications (macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine or other systematic, apart from T1D, which may hamper the implementation of the clinical study protocol or interpretation of results study.
  • Scheduled surgery during the study period.
  • Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
  • Subjects who are unlikely to meet the clinical study protocol, eg. uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
  • Using an experimental drug or device during the past 30 days.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínic de Barcelona

    Barcelona, 08036

Other trials in Spain

About this study

Official title: A Pilot Study Evaluating the Safety and Performance of an Artificial Pancreas With Carbohydrate Suggestion for Patients With Type 1 Diabetes Prone to Hypoglycemia

Achieving near-normoglycemia has been established as the main objective for most patients with Type 1 Diabetes (T1D). Automated insulin delivery (AID) systems, the so-called artificial pancreas (AP) or closed-loop systems, may represent the ideal solution, especially for patients not reaching the therapeutic goals with multiples doses of insulin or open-loop delivery systems. Despite the advances in recent years that have proven the efficacy and safety of these devices in clinical trials and clinical practice settings, such evidence cannot be extrapolated to highly unstable patients, as problematic hypoglycemia remains an exclusion criterion in most of the trials.

The SAFE-AP system is a single-hormone hybrid closed-loop controller based on a proportional derivative with an insulin feedback controller that integrates a safety layer with insulin-on-board constraints and sliding mode reference conditioning. The hybrid closed-loop system includes a second safety feedback loop with a controller that triggers carbohydrate recommendations to the patient. Both control loops are coordinated to ensure that the counter-regulatory effect of rescue carbohydrates is not counteracted with insulin. Such system has been previously proven effective in unannounced exercise, one of the main challenges in AID systems development. Additionally, the algorithm has been recently tailored to achieve a better control in the subgroup of T1D patients prone to hypoglycemia.

In this project, a rigorous clinical testing of the SAFE-AP system will be carried out in 12 patients with T1D and problematic hypoglycemia, despite treatment with continuous subcutaneous insulin infusion. The safety and performance of the system will be evaluated in a 32-hour pilot study, including 4 meals, one overnight period and 2 unannounced aerobic exercise sessions. The study will be performed in a hospital setting with the on-site supervision of a specialized nurse and a diabetologist, as well as an engineer in remote control.

Being tested
Automated Insulin Delivery System (SAFE-AP)
Keywords
Type 1 Diabetes, Hypoglycemia, Artificial Pancreas, Closed-loop, Automated insulin delivery
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.

  • Automated Insulin Delivery System (SAFE-AP)Device

    Each subject will undergo a 32-hour in-hospital study, including 4 meals (60 grams of carbohydrates each, except 50 grams for breakfast), one overnight period and 2 unannounced aerobic exercise sessions. Each exercise session consists of three 15-minute sets on a cycle ergometer at 70% of maximum heart rate with 5 minutes of rest between sets.

Study groups in NCT05628662
Study groupRoleWhat they receive
Automated Insulin Delivery System (SAFE-AP)ExperimentalSliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration. Automated insulin infusion based on subcutaneous continuous glucose monitoring (CGM). Commercially available insulin infusion systems and CGM devices will be used. However, insulin infusion will be driven by the software under investigation (SAFE-AP) based on blood glucose estimations from CGM.
Receives: Device: Automated Insulin Delivery System (SAFE-AP)

What is being measured

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

  1. Percentage of CGM time in glucose range 70-180 mg/dl during the study.

    Measured: From 12 AM of the first day of study until 4 PM of the second day of study

Secondary outcomes (15)

  1. Percentage of CGM time in glucose range 70-180 mg/dl during nighttime

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  2. Percentage of CGM time in glucose range 70-180 mg/dl during exercise and recovery

    Measured: Defined as 3 hours after exercise initiation

  3. Percentage of CGM time in glucose range 70-180 mg/dl during postprandial period

    Measured: Defined as 4 hours since mealtime

  4. Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during the study

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  5. Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during nighttime

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  6. Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during exercise and recovery

    Measured: Defined as 3 hours after exercise initiation

  7. Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during postprandial period

    Measured: Defined as 4 hours since mealtime

  8. Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during the study

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  9. Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during nighttime

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  10. Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during exercise and recovery

    Measured: Defined as 3 hours after exercise initiation

  11. Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during postprandial period

    Measured: Defined as 4 hours since mealtime

  12. Glucose coefficient of variation during the study

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  13. Number of hypoglycemic events

    Defined as sensor glucose <70 mg/dL during 15 minutes or symptomatic hypoglycemia confirmed with plasma glucose

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  14. Number of carbohydrate rescue events during the study

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

  15. Number of acute metabolic events during the study

    Defined as severe hypoglycemia and diabetic ketoacidosis

    Measured: From 22 PM of the first day of study until 7 AM of the second day of study

Timeline

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

  1. First posted29 Nov 2022
  2. Study start22 Oct 2021
  3. Primary completion6 Apr 2022
  4. Study completion6 Apr 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628662
Sponsor's protocol ID
HEAP
Status last verified
Nov 2022
First submitted
7 Nov 2022
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vinals C, Beneyto A, Martin-SanJose JF, Furio-Novejarque C, Bertachi A, Bondia J, Vehi J, Conget I, Gimenez M. Artificial Pancreas With Carbohydrate Suggestion Performance for Unannounced and Announced Exercise in Type 1 Diabetes. J Clin Endocrinol Metab. 2021 Jan 1;106(1):55-63. doi: 10.1210/clinem/dgaa562.

    PubMed 32852548

  • Rossetti P, Quiros C, Moscardo V, Comas A, Gimenez M, Ampudia-Blasco FJ, Leon F, Montaser E, Conget I, Bondia J, Vehi J. Closed-Loop Control of Postprandial Glycemia Using an Insulin-on-Board Limitation Through Continuous Action on Glucose Target. Diabetes Technol Ther. 2017 Jun;19(6):355-362. doi: 10.1089/dia.2016.0443. Epub 2017 May 1.

    PubMed 28459603

  • Quiros C, Bertachi A, Gimenez M, Biagi L, Viaplana J, Vinals C, Vehi J, Conget I, Bondia J. Blood glucose monitoring during aerobic and anaerobic physical exercise using a new artificial pancreas system. Endocrinol Diabetes Nutr (Engl Ed). 2018 Jun-Jul;65(6):342-347. doi: 10.1016/j.endinu.2017.12.012. Epub 2018 Feb 23. English, Spanish.

    PubMed 29483036

Questions about this trial

What is this clinical trial studying?

A study testing Automated Insulin Delivery System (SAFE-AP) in people with Type 1 Diabetes Mellitus Prone to Hypoglycemia, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 10 inclusion and 8 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 CGM time in glucose range 70-180 mg/dl during the study. (time frame: From 12 AM of the first day of study until 4 PM of the second day of study). 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 NCT05628662, which also lists 3 linked publications.

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 29 Nov 2022.

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