Diabetes trials combine a lab endpoint (HbA1c) with what participants measure at home: glucose readings and hypoglycaemia. This template pairs an HbA1c lab form with a phone glucose diary and a hypoglycaemia event form.
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Glucose diary
Tuesday · Day 12
Fasting glucose
Before dinner
Any low glucose or symptoms today?
At a glance
In trials
The HbA1c endpoint is measured at visits, usually by a central laboratory for consistency. Between visits, participants measure glucose at home at protocol-defined times, such as fasting, before meals and at bedtime, and report hypoglycaemia. Those home data support safety assessment, dose titration and secondary endpoints such as fasting glucose.
Home glucose data is only as good as its capture. A phone diary with a daily completion window, reminders and fixed units is far more reliable than a paper log transcribed at the next visit. For trials using continuous glucose monitors, see clinical trial software for CGM studies.
Record each hypoglycaemia episode on its own event form: date and time, glucose value if measured, symptoms, treatment, and whether assistance from another person was needed. Level 3 events are usually also adverse events, and serious ones follow SAE reporting.
Template
| Form | Completed by | Fields |
|---|---|---|
| HbA1c lab | Site | Sample date, result, unit (% or mmol/mol), lab, relevant conditions |
| Glucose diary | Participant | Readings at protocol times, unit fixed per study |
| Hypoglycaemia event | Participant or site | Date and time, glucose value, symptoms, treatment, assistance needed |
| Glucose-lowering medication | Site | Dose changes and titration decisions |
In Capture
Participants complete the glucose diary from a secure link with no app. Completion windows stop back-filling, reminders arrive when an entry is due, and range checks on site-entered values raise auto-queries. HbA1c results sit in the lab form with units, so both parts of the data are in one study.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Copy the template into the free sandbox.
Titration
Insulin and some other glucose-lowering trials adjust doses based on home glucose readings, often weekly according to a titration algorithm in the protocol. The data used for each decision, and the decision itself, should be recorded so that titration adherence can be reviewed. Recording the dose on each medication change keeps the link between glucose data and treatment clear.
For trials measuring wellbeing or diabetes distress alongside glucose, short questionnaires such as the WHO-5 fit easily into the same schedule.
Methods
For the primary endpoint, most trials use a central laboratory with a standardised, certified HbA1c method, so results are consistent across sites and countries. Point-of-care HbA1c devices are sometimes used for screening or between visits, but results can differ from the central lab.
Record the method and laboratory with each result, and state in the protocol which results count for eligibility and which for endpoints. If screening uses a point-of-care value and the baseline uses the central lab, participants near the eligibility threshold can fall on different sides, which is worth anticipating. See the lab results eCRF template.
Before go-live
% or mmol/mol, recorded with each result.
mg/dL or mmol/L fixed per study or country.
Protocol-defined times in the diary.
Levels 1 to 3 on the event form.
Dose decisions and the data behind them.
Anaemia, haemoglobin variants, transfusion.
Most trials use a central lab for the primary endpoint so results are consistent.
Sometimes for screening; state in the protocol which results count for eligibility and endpoints.
Average blood glucose over roughly the previous two to three months.
HbA1c in mmol/mol is about 10.93 times the percentage minus 23.5. Record the unit with each result.
Commonly as level 1 (below 70 mg/dL), level 2 (below 54 mg/dL) and level 3 (severe, needing assistance).
Yes. The diary opens from a secure link with no app, with windows and reminders.
Yes. Fix mg/dL or mmol/L per study or country so readings are comparable.
Yes. Copy it into your study in the free sandbox.
HbA1c, diaries and hypoglycaemia in one study. Free sandbox.