Linn 1996.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: newly diagnosed type 1 diabetes, adults Exclusion criteria: ‐ Diagnostic criteria: IDDM defined on the basis of insulin dependency according to WHO 1985 |
|
| Interventions |
Number of study centres: 1 Treatment before study: ‐ |
|
| Outcomes | Outcomes reported in abstract of publication: glucagon‐stimulated C‐peptide, microalbuminuria, retinopathy, neuropathy, HbA1c, hypoglycaemia frequency, insulin sensitivity | |
| Study details |
Run‐in period: ‐ Study terminated before regular end: no |
|
| Publication details |
Language of publication: English Funding: ‐ Publication status: peer‐reviewed journal/full article |
|
| Stated aim of study | Quote from publication: "In this study, intensive insulin treatment was initiated in newly diagnosed adult patients to determine if it preserved endogenous insulin secretion longer than conventional therapy" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "…randomizations was performed with the use of computer‐selected random numbers" Comment: considered adequate |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) Objective Outcomes | Low risk | Quote from publication: "The I group contacted the diabetes educator by visit or telephone once per month to review and adjust the regimens". Comment: neither participants nor personnel blinded, but risk of bias considered low for objective outcomes |
| Blinding of participants and personnel (performance bias) Subjective Outcomes | High risk | Quote from publication: "The I group contacted the diabetes educator by visit or telephone once per month to review and adjust the regimens". Comment: neither participants nor personnel blinded |
| Blinding of outcome assessment (detection bias) Objective Outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) Subjective Outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote from publication: "Forty‐two of 49 randomised patients completed the 5 years, and only their data were included" Comment: no reasons given for the withdrawals, analysis not ITT |
| Selective reporting (reporting bias) | Unclear risk | Comment: information insufficient to make judgement |
| Other bias | Unclear risk | Comment: no other risks of bias found, but amount of information considered insufficient to make judgement |