Trial Outcomes & Findings for IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE) (NCT NCT05516797)

NCT ID: NCT05516797

Last Updated: 2025-03-26

Results Overview

Change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-month Post-Dietary Change period between participants with T2D who are randomized to use either BGM or CGM (3 months minus baseline)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 178 participants
• Primary outcome timeframe: Three (3) months
• Results posted on: 2025-03-26

Participant Flow

All participants were required to complete a baseline assessment period prior to beginning the intervention. This included wearing a blinded CGM for up to 14-days along with assessment of HbA1c and completion of several surveys. More participants were enrolled than were randomized. Some participants who enrolled did not complete the required baseline assessment requirements for randomization or they voluntarily withdrew before randomization. This is why N=178 enrolled and N=163 were randomized.

Participant milestones

Measure	Continuous Glucose Monitoring (CGM) Arm Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Overall Study STARTED	81	82
Overall Study COMPLETED	72	64
Overall Study NOT COMPLETED	9	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE)

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring (CGM) Arm n=81 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=82 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.	Total n=163 Participants Total of all reporting groups
Age, Continuous	53.5 years STANDARD_DEVIATION 9.7 • n=5 Participants	52.3 years STANDARD_DEVIATION 9.3 • n=7 Participants	52.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Hb1ac	8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 • n=5 Participants	8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 • n=7 Participants	8.1 percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: Three (3) months

Population: Participants with adequate blinded CGM data at baseline and at month 3 were included.

Change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-month Post-Dietary Change period between participants with T2D who are randomized to use either BGM or CGM (3 months minus baseline)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline)	28 percentage of time with glucose 70-180 m Interval 21.0 to 34.0	22 percentage of time with glucose 70-180 m Interval 15.0 to 29.0

SECONDARY outcome

Timeframe: Three (3) months / 90 days

Population: Results from general and generalized linear mixed models using all available data

Mean of blood ketone levels from day 0 to day 90 (three months).

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=79 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=81 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
90-day Mean Blood Ketone Levels	0.54 mmol/L Interval 0.47 to 0.61	0.48 mmol/L Interval 0.42 to 0.55

SECONDARY outcome

Timeframe: Three (3) months

Population: Some data missing at random; used all available and qualifying data

Percent of participants reaching CGM-derived consensus targets (targets defined as meeting both >70% TIR70-180 mg/dL and <4% TBR <70mg/dL) at the end of the 3-month Post-Dietary in both the BGM and CGM arms

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Participants Reaching CGM-derived Consensus Targets	81 percentage of participants Interval 70.0 to 89.0	66 percentage of participants Interval 53.0 to 78.0

SECONDARY outcome

Timeframe: Three (3) months

Population: Some data missing at random; all available and qualifying data were used

Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in HbA1c	-1.6 percentage of glycated hemoglobin Interval -1.8 to -1.3	-1.5 percentage of glycated hemoglobin Interval -1.7 to -1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Three (3) months

Population: Some data were missing at random; analysis used all available qualifying data

Change in the % time above range >180 mg/dL, during the Baseline to 3-month Post-Dietary Change period for both arms (3 months minus baseline)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in CGM-derived Metric %Time Above Range >180 mg/dL During 3-month Post-Dietary Change Period (3 Month Minus Baseline)	-28 percent time with glucose >180mg/dL Interval -34.0 to -21.0	-23 percent time with glucose >180mg/dL Interval -30.0 to -17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months (baseline to three months)

Population: some data missing at random; all available and qualifying data were used

Change in %Time below range <70 mg/dL during the Baseline to 3-month Post-Dietary Change period (3 months minus baseline)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in the CGM-derived Metric, %Time Below Range <70 mg/dL (3 Months Minus Baseline)	0.7 percent time with glucose <70mg/dL Interval 0.0 to 1.5	1.2 percent time with glucose <70mg/dL Interval 0.4 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Three (3) months (baseline to three months)

Population: some data missing at random; all available and qualifying data were used

Change in % Time with glucose below range <54 mg/dL from Baseline to 3-month Post-Dietary Change (3 months minus baseline)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in the CGM-derived Metric %Time Below Range <54 mg/dL, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	-0.01 percent time with glucose <54 mg/dL Interval -0.09 to 0.06	0.04 percent time with glucose <54 mg/dL Interval -0.09 to 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Three (3) months (baseline to three months)

Population: some data missing at random; all available and qualifying data were used

Change in the CGM-derived metric, Mean sensor glucose, from baseline to three months

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in the CGM-derived Metric, Mean Sensor Glucose, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	-48 mg/dL Interval -58.0 to -37.0	-42 mg/dL Interval -53.0 to -31.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Three (3) months (baseline to three months)

Population: some data missing at random; all available and qualifying data were used

Change in % Coefficient of variation from Baseline to 3-month Post-Dietary Change (3 months minus baseline)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) Arm n=72 Participants Participants in this arm took part in a medically supervised ketogenic diet program. They wore and used a Freestyle Libre 2 continuous glucose monitoring system on thier personal smartphone during the entire intervention period.	Blood Glucose Monitoring (BGM) Arm n=64 Participants Participants in this arm took part in a medically supervised ketogenic diet program. The BGM arm participants used a Precision Xtra Blood Glucose and Ketone Monitoring System (Abbott Diabetes Care) daily; fingerstick glucose testing was prescribed on an individual basis. Participants in this arm also wore a blinded Freestyle Libre Pro continuous glucose monitoring system during specified intervals throughout the intervention period.
Difference in Change in the CGM-derived Metric, % Coefficient of Variation, From Baseline to 3-month Post-Dietary Change Period (3 Months Minus Baseline)	-4 percent of coefficient of variation Interval -6.0 to -3.0	-4 percent of coefficient of variation Interval -5.0 to -2.0

Adverse Events

Continuous Glucose Monitoring (CGM) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blood Glucose Monitoring (BGM) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Holly Willis

HealthPartners Institute

Phone: 952-993-3219

Email: holly.willis@parknicollet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place