Study design · Continuous glucose monitoringUpdated September 29, 2026

Clinical trial software for CGM studies

Continuous glucose monitors produce hundreds of readings a day. Studies need the right summary metrics, enough valid wear time, and the context that explains the curves: meals, activity, medication. Capture holds CGM metrics, wear periods and participant logs next to the rest of the study data.

  • Consensus CGM metrics as fields
  • Wear periods tracked
  • Meal and activity logs on phones

Free sandbox · No credit card · 21 CFR Part 11 aligned

CGM summary · Subject 010-0006 · 14 days

Time in range 70-180

74%

Time below 70

2.1%

Data sufficiency

93%

Time above 2504/100
Time 181 to 25020/100
Time 70 to 18074/100
Time below 702/100
Summary metrics from the CGM platform

What matters in CGM studies

  • International consensus defines core CGM metrics: time in range (70 to 180 mg/dL, 3.9 to 10.0 mmol/L), time below range (below 70 and below 54 mg/dL), time above range, mean glucose, glucose management indicator and coefficient of variation.
  • Common targets for most adults with type 1 or type 2 diabetes include more than 70% time in range, less than 4% below 70 mg/dL and less than 1% below 54 mg/dL.
  • Metrics need enough data: consensus recommends about 14 days with at least 70% of possible readings.
  • Studies may use blinded (masked) CGM, where participants do not see readings, to avoid changing behaviour, or unblinded CGM as part of the intervention.
  • CGM is increasingly used beyond diabetes, for example in nutrition, obesity and metabolic health research.

Study design

Wear periods, data sufficiency and context

A CGM endpoint is calculated over a wear period, usually around 14 days before a visit. If a sensor falls off, fails or is removed, the period may not have enough data to be valid. Studies define in advance what counts as sufficient data, track sensor start and end dates, and plan what happens when a period is incomplete, such as extending wear or using the next period.

Glucose curves also need context. A spike after a meal means something different from one after a missed insulin dose. Short participant logs of meals, activity, illness and hypoglycaemia symptoms, completed on their phone, explain what the numbers show and support exploratory analyses.

Where the raw data lives

Raw CGM readings usually stay in the manufacturer's platform or a dedicated data repository, exported for analysis. The study database holds device and sensor identifiers, wear periods, summary metrics and the link to the raw data, so every reported metric can be traced. See digital biomarker validation study software for the same pattern with other devices.

Daily log

Wednesday · CGM wear day 6

Meals today

3

Exercise today

NoneLightModerateVigorous

Hypoglycaemia symptoms

NoYes

Sensor still attached

YesNo
Context for the glucose curve

CGM metrics

Summary metrics as structured, checked fields

Record each wear period's metrics as numeric fields with units and range checks: time in range, time below and above range, mean glucose, GMI, coefficient of variation and percentage of readings captured. Sensor identifiers and start and end dates sit on the same form, so every metric has its source period.

  • Numeric fields with range checks.
  • Sensor IDs and wear dates.
  • Exports with codes and labels.
EDC for diabetes trials
Vital signs · Systolic blood pressure

Edit checks / auto-queries

2
Auto-query

Type

Range High

Operator

Greater than

Value

180

Priority: High

Auto-query

Type

Range Low

Operator

Less than

Value

80

Priority: Normal

Query raised automatically

Value 192 violates limit (180). Please verify.

Build a CGM metrics form and daily log

Try both in the free sandbox.

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Consensus metrics

Core CGM metrics and common targets

MetricDefinitionCommon target (most adults with diabetes)
Time in range70 to 180 mg/dL (3.9 to 10.0 mmol/L)More than 70%
Time below range, level 1Below 70 mg/dL (3.9 mmol/L)Less than 4%
Time below range, level 2Below 54 mg/dL (3.0 mmol/L)Less than 1%
Time above rangeAbove 180 mg/dL; above 250 mg/dLLess than 25%; less than 5%
Coefficient of variationGlycaemic variability36% or less
Data sufficiencyReadings captured over the periodAt least 70% over about 14 days

Targets differ for older or high-risk adults, pregnancy and children. Use the targets and definitions in your protocol.

Beyond diabetes

CGM in nutrition and metabolic research

People without diabetes are increasingly wearing CGMs in research on diet, weight management, sleep and exercise. These studies often focus on post-meal glucose responses rather than time in range, which makes accurate meal timing and composition the critical data. Standardised test meals at defined times, logged precisely, produce the most reliable comparisons.

For nutrition studies, see clinical trial software for nutrition research, and for glycaemic logs and HbA1c, the HbA1c and glycemic log template.

Study build

CGM study build checklist

Metric definitions

Consensus metrics and targets in the protocol.

Wear periods

Length, timing before visits and sufficiency threshold.

Blinded or unblinded

Whether participants see their readings.

Sensor tracking

Sensor IDs, start and end dates, failures.

Context logs

Meals, activity, illness and symptoms.

Raw data plan

Where raw readings live and how they link to the study.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is time in range?

The percentage of CGM readings between 70 and 180 mg/dL (3.9 to 10.0 mmol/L). More than 70% is a common target for most adults with diabetes.

How much CGM data is enough?

Consensus recommends about 14 days with at least 70% of possible readings captured.

Does Capture integrate directly with CGM devices?

Studies record CGM summary metrics, sensor identifiers and wear periods as structured fields. Raw readings usually stay in the device platform and are exported for analysis.

What is blinded CGM?

CGM where participants cannot see their readings, used to measure glucose without changing behaviour.

Can participants log meals on their phone?

Yes. Daily logs open from a secure link with no app, with windows and reminders.

Can I try it free?

Yes, in the free sandbox with every feature.

CGM metrics with their context

Wear periods, metrics and logs in one study. Free sandbox.

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