Current partner codePEPTIDESDE
NCT04163874·Not applicable·INTERVENTIONAL

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Status

Completed

Phase

Not applicable

Enrollment

36

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.

Interventions

Treatment arms and agents.

DRUG

Fiasp

Fiasp Insulin delivered in a basal-bolus manner.

DRUG

Pramlintide Acetate

Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.

DRUG

Placebo

Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.

DEVICE

Artificial Pancreas

Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Timeline

From registration to results.

  1. First posted

    Nov 15, 2019

  2. Study start

    Feb 14, 2020

  3. Primary completion

    Jan 30, 2022

  4. Study completion

    Jan 30, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Oct 10, 2022

Outcomes

What the study measures.

Primary outcomes

Each participant's time in target range

Time frame · 12 days

Time in target range (3.9-10mmol/L)

Mean score of the Emotional Burden section of the Diabetes Distress Scale

Time frame · 12 days

Average of all question's scores (from 1-6). Higher score means more emotional burden.

Secondary outcomes

Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Time frame · 12 days

Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L

Time frame · 12 days

Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L

Time frame · 12 days

Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L

Time frame · 12 days

Each participant's mean glucose level

Time frame · 12 days

Each participant's standard deviation of glucose levels as a measure of glucose variability

Time frame · 12 days

Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L

Time frame · 12 days

Each participant's number of Gastrointestinal symptoms

Time frame · 12 days

Each participant's total insulin delivery

Time frame · 12 days

Eligibility

Who can take part.

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

Inclusion Criteria: 1. Signed and dated written informed consent 2. Males and females ≥ 12 years of age 3. HbA1c ≤ 12% 4. Insulin pump use for at least 3 months 5. Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned. 6. Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced \[the first occurrence of menstruation\] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Exclusion Criteria: Participants who meet any of the following criteria are not eligible for the study: 1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…). 2. Current use of glucocorticoid medication. 3. Use of medication that alters gastrointestinal motility. 4. Planned or ongoing pregnancy. 5. Breastfeeding individuals. 6. Severe hypoglycemic episode within one month of admission. 7. Severe diabetes ketoacidosis episode within one month of admission. 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. Known hypersensitivity to any of the study drugs or their excipients. 11. Individuals with confirmed gastroparesis. 12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 13. Unable to travel to research center within 3h if needed during study interventions 14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.). Study Discontinuation/Withdrawal 1. Failure to comply with the protocol. 2. Pregnancy. 3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

Study locations

1 registered sites.

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

3555 University Street

Montreal, Quebec, Canada

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.