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

Type 2 Diabetes Clinical Trial

— CGM-DTx  

Official title:

An Exploratory 16-Week Pilot Study of the Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs, in Type 2 Diabetes Mellitus Participants Treated With Basal Insulin.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111508
• Other study ID #: 230357
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2024
• Source: University of Virginia
• Contact: Marc D Breton, Ph.D.
• Phone: 4349826484
• Email: mb6nt[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

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.

7. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time in Range	Change in CGM-measured time in range 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm.	From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
Secondary	Change in HbA1c	Percent change in HbA1c	From week 0 to week 16
Secondary	Change in Time in Tight Range	Percent change in time in tight range 3.9-7.8 mmol/L (70-140 mg/dL)	From baseline (week -2-0) to week 14-16
Secondary	Change in Time above 10.0 mmol/L (180 mg/dL)	Percent of time spent above 10.0 mmol/L (180 mg/dL).	From baseline (week -2-0) to week 14-16
Secondary	Change in Time above 13.9 mmol/L (250 mg/dL)	Percent of time spent above 13.9 mmol/L (250 mg/dL)	From baseline (week -2-0) to week 14-16
Secondary	Change in Continuous Glucose Monitoring Coefficient of variation (%)	The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level.	From baseline (week -2-0) to week 14-16
Secondary	Change in Mean Glucose Level	The average CGM-measured blood glucose level (mmol/L).	From baseline (week -2-0) to week 14-16
Secondary	Change in Time below 3.9 mmol/L (70 mg/dL)	Percent of time spent below 3.9 mmol/L (70 mg/dL).	From baseline (week -2-0) to week 14-16
Secondary	Change in Time below 3.0 mmol/L (54 mg/dL)	Percent of time spent below 3.0 mmol/L (54 mg/dL).	From baseline (week -2-0) to week 14-16
Secondary	Frequency of Hypoglycemic Events	The number of clinically significant hypoglycemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycemic episodes (level 3).	From week 0 to week 16
Secondary	Frequency of Serious Adverse Events	The number of serious adverse events (SAEs).	From week 0 to week 16
Secondary	Frequency of Treatment Emergent Adverse Events	The number of treatment emergent adverse events (TAEs).	From week 0 to week 16
Secondary	Frequency of Device Deficiencies	The number of device deficiencies (DDs). A device malfunction is any failure of a device to meet its performance specifications or otherwise work as intended. Performance specifications include all claims made in the labelling for the device. The intended performance of a device refers to the intended use for which the device is labelled or marketed.	From week 0 to week 16
Secondary	Percent Acceptance Rate	Investigator acceptance rate of weekly dose guidance - from CGM-based titration (Experimental arm only).	From week 0 to week 16
Secondary	Frequency of Dose Changes	The investigator changes the dose from the recommended or the current dose (Experimental arm only).	From week 0 to week 16