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NCT03800875·Phase 2·INTERVENTIONAL

Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

PramlintideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

24

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user.

Full detailed description

Meal carbohydrate content is the main determinant of prandial insulin needs, and consequently, accurate carbohydrate counting is recommended for type 1 diabetes. Advances in glucose sensors have motivated the development of the closed-loop system to automatically regulate glucose levels in individuals with type 1 diabetes. In the closed-loop system, a dosing algorithm adjusts the pump insulin infusion rate based on continuous glucose sensor readings. Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user. Thus, the two hormones' role in the postprandial state will be as follows: 1. Insulin: to reduce plasma glucose levels. Insulin delivery needs to be aggressive to counter-act fast increase in post-meal glucose levels. 2. Pramlintide: to slow gastric emptying and aim insulin in efficiently controlling postprandial glucose levels. The aim of this study is to assess a fully automated, dual-hormone, closed-loop system that delivers insulin, and pramlintide to control glucose levels without degrading overall glycemic control compared to an insulin-alone closed-loop system with carbohydrate-matched boluses. The investigators hypothesize that the dual-hormone closed-loop system will alleviate carbohydrate-counting burden (fully reactive system) without degrading glucose control compared to the insulin-alone closed-loop system.

Interventions

Treatment arms and agents.

DRUG

27-hour inpatient intervention

Subjects will be admitted at the research facility at 19:00. Each 27-hour intervention visit includes 3 standardized meals (8:00, 12:00, and 17:00), an evening snack (22:00) and an overnight stay. The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes. The infusion rate of either insulin alone or insulin and pramlintide will be changed manually based on the computer generated recommendation. The computer generated recommendations are based on a predictive algorithm.

Timeline

From registration to results.

  1. First posted

    Jan 11, 2019

  2. Study start

    Feb 8, 2019

  3. Primary completion

    Sep 19, 2020

  4. Study completion

    Sep 19, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jun 8, 2021

Outcomes

What the study measures.

Primary outcomes

Total percentage of time (22:00-22:00) that the glucose concentration remained within 3.9 and 10.0 mmol/L

Time frame · 24 hours

Secondary outcomes

Total percentage of time (22:00-22:00) that the glucose concentration remained within specified ranges.

Time frame · 24 hours

a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. between 3.9 and 10 mmol/L d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.

Percentage of overnight time (24:00-8:00) that the glucose concentration remained within specified ranges.

Time frame · 8 hours

a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.

Total amount of insulin delivered to the participant

Time frame · 24 hours

Mean sensor glucose concentration during the overnight stay

Time frame · 8 hours

Number of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day

Time frame · 27 hours

The number and severity of gastrointestinal sysmptoms experienced by a participant

Time frame · 27 hours

GI symptoms include: nausea, vomiting, bloating and heartburn

Mean daytime insulin concentration

Time frame · 14 hours

Mean daytime concentration of amylin

Time frame · 14 hours

Total amount of pramlintide delivered to the participant

Time frame · 24 hours

Mean glucose level

Time frame · 24-hour period

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Males and females ≥ 18 years of age. 2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed. 3. Insulin pump therapy for at least 6 months. 4. HbA1c ≤ 12% in the last 6 months. Exclusion Criteria: 1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…). 2. Severe hypoglycemic episode within one month of admission. 3. Severe diabetic ketoacidosis episode within one month of admission. 4. Pregnancy. 5. Known or suspected allergy to the study drugs. 6. Gastroparesis. 7. Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide). 8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 9. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 10. Current use of glucocorticoid medication. 11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 12. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

McGill University Health Centre

Montreal, Quebec, Canada

Publications

Results and literature.

PMID 34580055 ↗Tsoukas MA, Majdpour D, Yale JF, Fathi AE, Garfield N, Rutkowski J, Rene J, Legault L, Haidar A. A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial. Lancet Digit Health. 2021 Nov;3(11):e723-e732. doi: 10.1016/S2589-7500(21)00139-4. Epub 2021 Sep 24.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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