Type 1 diabetes trials mix endpoints that need timed lab draws (C-peptide after a mixed meal), safety events that can be dangerous (ketoacidosis, severe lows), daily insulin data and, very often, a child whose parent answers the questions. Capture builds each as its own form on one record, with phone reports and an audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Conditions
Fasting duration
FASTHRBasal insulin taken as usual
BASALOKGlucose before meal
GLUPREC-peptide draws
0 min
CPEP060 min
CPEP60120 min
CPEP120Draw time 126 min. Outside window of ±5 min, deviation logged.
What a type 1 diabetes trial needs from its EDC
The study data
Type 1 diabetes research spans several questions that need different data. Disease-modifying trials in new-onset disease ask whether a treatment preserves the participant’s own insulin-making capacity, and registered protocols often make the change in C-peptide area under the curve over a 2-hour (0 to 120 minute) or 4-hour mixed meal tolerance test the primary endpoint, with HbA1c as a co-primary or key secondary. Prevention studies enrol people who have islet autoantibodies but no symptoms, and follow them for progression. Technology trials compare insulin pumps, automated insulin delivery or glucose monitoring strategies, where the outcomes are time in range and hypoglycaemia. Adjunct-drug trials add a medicine to insulin and watch HbA1c, insulin dose and weight.
What these share is that the data points are timed, units matter and safety is not an afterthought. A mixed meal test is a five- or six-row table with the time each sample was actually drawn. HbA1c can arrive in percent or mmol/mol depending on the central lab. Hypoglycaemia is classified by the widely used American Diabetes Association levels: level 1 below 70 mg/dL, level 2 below 54 mg/dL and level 3 as a severe event with cognitive impairment needing outside assistance. Your protocol states the definitions in force and the EDC should store the glucose value, the level and the assistance given as separate answers.
This page is deliberately specific to type 1 disease. For HbA1c units, general lab ranges and the wider diabetes endpoint set in adults, see EDC for diabetes clinical trials, and for the CGM summary-metric workflow see clinical trial software for CGM studies.
Capture does not connect to glucose sensors or insulin pumps in this context, and this page makes no device-integration claim. Raw sensor and pump files stay in the device vendor’s platform or with a central reader. What the eCRF holds are the summary metrics the study team enters or imports for each assessment period (percent time in range, below range, above range, wear time) with the source recorded, plus any manual events such as a pump failure. Agree the transfer in the data management plan before the first visit.
Median time in range
68%
Median HbA1c
7.4%
Level 3 events
2
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Diagnosis date, autoantibody results, C-peptide threshold, age, prior therapy | Eligibility form with edit checks on dates and thresholds |
| Beta-cell function | Timed C-peptide draws, glucose, actual draw time, test conditions | Visit form with one field per time point and a deviation flag |
| Glycaemic control | HbA1c with unit, CGM summary metrics, fasting glucose | Lab results with reference ranges; summary metrics entered by the study team |
| Insulin | Daily dose, basal and bolus, delivery method, changes | Repeating dosing form and a short phone diary |
| Hypoglycaemia | Date and time, lowest glucose, level, assistance needed | Event log form with level as a structured field |
| DKA | Date, pH and bicarbonate or ketones, hospital admission, precipitating cause | Event form linked to the adverse event form |
| Child and parent reports | Child quality of life, parent proxy report, diabetes distress | Separate phone questionnaires; see parent proxy ePRO and the PedsQL template |
| Safety | Adverse events, injection-site or infusion reactions, immune events | Adverse event form and SAE report form |
Capture records the data your protocol defines. Disease staging, endpoints and clinical decisions belong to the protocol and the investigators.
Upload the protocol, let the AI draft the visits and forms for review, then enter a late draw and a high glucose and see what the site and the monitor see. Free sandbox.
Safety reporting
Diabetic ketoacidosis and severe hypoglycaemia are the two events that sponsors and data monitoring committees watch most closely in type 1 trials, and registered protocols count treatment-emergent ketoacidosis episodes as a named safety outcome. Their definitions vary by protocol, so use a form that captures the ingredients: glucose, ketone or blood gas values where measured, admission and treatment, and the investigator’s assessment of cause. Keep severity, seriousness and causality as separate answers; the AE causality assessment page and the AE seriousness decision tree explain the split, and the SAE reporting deadline calculator helps with planning clocks.
An edit check in Capture raises a query for site review when a value breaks a rule, for example a glucose entry below the level 2 threshold with level 1 selected. That is a data-cleaning tool, not a clinical alert. Urgent escalation is a study procedure, and the form should record that it was followed. For alert-level lab values routed to a medical monitor, see lab data and reference range management.
Immunotherapy trials add their own safety items: infusion reactions, lymphocyte counts, infections and immune-related events. Build those as repeating lab and event rows under the same adverse event process.
Cannot submit yet
Causality is required because the event is serious.
Children, adolescents and parents
A large share of type 1 research enrols children and adolescents. A parent or caregiver answers on behalf of a young child, an adolescent answers their own questions and the parent adds a separate report, and diabetes distress is often measured in both. In Capture these are separate phone questionnaires with their own tasks and timestamps, so the analysis can tell whose answer it is. See EDC for childhood obesity clinical trials for the related paediatric data pattern, and eConsent for clinical trials for parental permission and assent templates in the consent library.
Role-based access keeps names with the site coordinator and coded IDs with researchers, which is useful when the participant is a minor. Exports come as CSV or Excel with an automatic data dictionary, and SDTM datasets as SAS XPT with Define-XML (SDTM export).
Build sequence
A realistic order of work for a sponsor, academic group or consortium.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
One value and one actual time per draw, test-condition fields, range checks and a deviation flag for draws outside the window.
Insulin dosing, hypoglycaemia log by level and a DKA form linked to adverse events.
Separate phone instruments with reminders and completion windows; licences for named instruments stay with your study documents.
Run practice participants through a late draw, a level 3 event and a DKA admission, approve the forms and start the paid live phase when real participants enrol.
Before first participant
C-peptide window and time points, HbA1c unit, time-in-range rule and event definitions for DKA and level 3 hypoglycaemia.
Fasting, insulin and meal conditions on the form, with a deviation path.
Who imports summary metrics, in what format, and how the source is recorded.
Who reviews a severe event, how fast, and the form that records the call.
Who answers which instrument and who consents or assents.
Wide CSV with data dictionary opened in the statistics package.
Yes. Build a visit form with one value and one actual draw time per time point, test-condition fields and a deviation flag. Edit checks and calculated fields help with ranges.
No device integration is claimed here. CGM summary metrics and pump events can be entered or imported by the study team into the eCRF with the source recorded.
Use structured event forms with level, glucose, treatment and assessment as separate fields, linked to the adverse event and SAE process.
Yes. They are separate phone questionnaires with their own tasks, so the analysis knows who answered.
That page covers HbA1c units, lab ranges and CGM metrics for diabetes generally. This one covers type 1 specifics: beta-cell function tests, ketoacidosis, paediatric reporting and insulin data.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for diabetes clinical trials
HbA1c units, lab ranges and glycaemic endpoints.
Clinical trial software for CGM studies
CGM summary metrics in the eCRF.
Adverse event eCRF template
Severity, seriousness and causality as separate fields.
PedsQL eCRF template
Paediatric quality-of-life form structure.
Capture ePRO
Phone questionnaires, reminders and completion windows.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.