The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.

NCT ID: NCT06111508

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2024-09-16

Brief Summary

The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).

Detailed Description

This is an 18-week study designed to investigate the effect of a continuous glucose monitor (CGM) based titration algorithm versus a standard titration by self-monitoring blood glucose (SMBG) on glycemic control in Type 2 Diabetes (T2DM) participants using insulin Degludec. After 2 weeks of blinded CGM baseline observation, participants are randomized 2:1 to CGM-based titration or standard titration by SMBG for 16 weeks. In the SMBG group, all titrated doses will be reviewed by a study physician prior to use and participants will wear a blinded CGM during the whole study. After completion of the 16-week titration, participants are followed up for 2 days. Participants will be divided related to use of sulfonylureas or glinides with a maximum cap of nine participants being treated with sulfonylureas and glinides to complete the study.

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

Continuous Glucose Monitoring (CGM) based Titration

The CGM-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. For dose computation the algorithm is comprised of three components; titration glucose level, personalized target, and safety hypoglycemia feature.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs

Intervention Type: DEVICE

A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform

Standard Self-Monitoring Blood Glucose (SMBG) Titration

The SMBG-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. Participants in the standard SMBG based titration group will wear a blinded CGM during the whole study. The total daily basal insulin dose will be converted 1:1 to Degludec. Algorithm informed dose changes will be made once weekly and checked by study physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs

A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform

Intervention Type: DEVICE

Other Intervention Names

Degludec

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older at signing of informed consent

2. Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening

3. Hemoglobin A1c between 7-9% and measured by local lab at screening

4. On daily basal insulin for at least 90 days before inclusion into the study

5. Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:

1. Metformin

2. Sulfonylureas

3. Meglitinides (glinides)

4. Dipeptidyl peptidase 4 (DPP-4) inhibitors

5. Sodium glucose co-transporter 2 (SGLT2) inhibitors

6. Thiazolidinediones

7. Alpha-glucosidase inhibitors

8. Oral combination products (for the allowed individual oral anti-diabetic drugs)

9. Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs)

10. If on sulfonylureas or glinides, willingness to reduce dose by 50%

8. Known skin reactions to CGM adhesives

9. Current/prior use of CGM within 30 days of the screening visit

10. Any planned surgery or procedures where basal insulin would be decreased or held in anticipation

Exclusion Criteria

1. Hypersensitivity to Degludec

2. Use of an insulin pump

3. Use of a short-acting insulin

4. Participation or has participated in another trial within 90 days of the screening visit

5. Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method

6. Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.

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

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralf M Nass, MD

Role: STUDY_CHAIR

University of Virginia

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

230357

Identifier Type: -

Identifier Source: org_study_id