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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs

• Registration Number: NCT06111508
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Study Start: 2023-11-29
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring (CGM) based Titration	Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs	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.

Primary Outcome Measures

Name	Time	Method
Change in Time in Range	From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of Serious Adverse Events	From week 0 to week 16	The number of serious adverse events (SAEs).
Change in HbA1c	From week 0 to week 16	Percent change in HbA1c
Change in Continuous Glucose Monitoring Coefficient of variation (%)	From baseline (week -2-0) to week 14-16	The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level.
Frequency of Hypoglycemic Events	From week 0 to week 16	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).
Percent Acceptance Rate	From week 0 to week 16	Investigator acceptance rate of weekly dose guidance - from CGM-based titration (Experimental arm only).
Frequency of Dose Changes	From week 0 to week 16	The investigator changes the dose from the recommended or the current dose (Experimental arm only).
Change in Time in Tight Range	From baseline (week -2-0) to week 14-16	Percent change in time in tight range 3.9-7.8 mmol/L (70-140 mg/dL)
Change in Mean Glucose Level	From baseline (week -2-0) to week 14-16	The average CGM-measured blood glucose level (mmol/L).
Change in Time below 3.9 mmol/L (70 mg/dL)	From baseline (week -2-0) to week 14-16	Percent of time spent below 3.9 mmol/L (70 mg/dL).
Change in Time above 10.0 mmol/L (180 mg/dL)	From baseline (week -2-0) to week 14-16	Percent of time spent above 10.0 mmol/L (180 mg/dL).
Change in Time above 13.9 mmol/L (250 mg/dL)	From baseline (week -2-0) to week 14-16	Percent of time spent above 13.9 mmol/L (250 mg/dL)
Change in Time below 3.0 mmol/L (54 mg/dL)	From baseline (week -2-0) to week 14-16	Percent of time spent below 3.0 mmol/L (54 mg/dL).
Frequency of Treatment Emergent Adverse Events	From week 0 to week 16	The number of treatment emergent adverse events (TAEs).
Frequency of Device Deficiencies	From week 0 to week 16	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.

Trial Locations

Locations (2)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States