Clinical trial NCT06111508: The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Continuous Glucose Monitoring (CGM)
Degludec Insulin
Self-monitoring blood glucose (SMBG)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2023-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, randomized, parallel group, active-comparator clinical trial of CGM based titration of insulin Degludec vs. standard titration by SMBG.
Primary purpose: TREATMENT

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.

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%

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

Primary outcomes:
measure: Change in Time in Range
timeFrame: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From week 0 to week 16
measure: Change in Time in Tight Range
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Time above 10.0 mmol/L (180 mg/dL)
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Time above 13.9 mmol/L (250 mg/dL)
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Continuous Glucose Monitoring Coefficient of variation (%)
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Mean Glucose Level
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Time below 3.9 mmol/L (70 mg/dL)
timeFrame: From baseline (week -2-0) to week 14-16
measure: Change in Time below 3.0 mmol/L (54 mg/dL)
timeFrame: From baseline (week -2-0) to week 14-16
measure: Frequency of Hypoglycemic Events
timeFrame: From week 0 to week 16
measure: Frequency of Serious Adverse Events
timeFrame: From week 0 to week 16
measure: Frequency of Treatment Emergent Adverse Events
timeFrame: From week 0 to week 16
measure: Frequency of Device Deficiencies
timeFrame: From week 0 to week 16
measure: Percent Acceptance Rate
timeFrame: From week 0 to week 16
measure: Frequency of Dose Changes
timeFrame: From week 0 to week 16
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Ralf M Nass, MD
role: STUDY_CHAIR
References: